Ingredient record · Nasal decongestant
Phenylephrine: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
156 entries containing Phenylephrine are on India's banned-drugs list, and 84 are banned today. 122 batches of medicines containing Phenylephrine failed a government lab test between March 2020 and September 2026, from 97 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Is it banned? Our answer pages
On the banned-drugs list
Phenylephrine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Chlorpheniramine Maleate + Phenylephrine Hydrochloride (all formulations; children below 4 years)Fixed-dose combination · cough-cold | Restricted | S.O. 4595(E) | 18 August 2026 | Other orders | Restricted, not banned: extends the 15.04.2025 condition to ALL formulations containing CPM + PE, label/insert/promotional warning 'FDC shall not be used in children below four years of age'. S.O. number per PIB press release of 22.08.2026. |
| Chlorpheniramine Maleate + Phenylephrine Hydrochloride (children below 4 years)Fixed-dose combination · cough-cold | Restricted | S.O. 1717(E) | 15 April 2025 | Other orders | Restricted, not banned: manufacture/sale/distribution subject to the label warning 'FDC shall not be used in children below four years of age' (certain formulations). Preceded by CDSCO letter 18.12.2023 requiring the same warning on CPM 2mg + PE 5mg drop/ml. S.O. number per PIB press release of 22.08.2026. |
| Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride 5mg per 5ml Syrup & Diphenhydramine Hydrochloride 12.5mg + Phenylephrine Hydrochloride 5mg per 5ml SyrupFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 4 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Boric Acid + Phenylephrine HCl + Naphazoline Nitrate + Menthol + CamphorFixed-dose combination · eye | Banned | S.O. 3356(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Chlorpheniramine Maleate + Phenylephrine HCl + AntipyrineFixed-dose combination · cough-cold | Banned | S.O. 3361(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl CelluloseFixed-dose combination · cough-cold | Banned | S.O. 3362(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Naphazoline HCl + Phenylephrine HCl + HPMC + Chlorpheniramine Maleate + Menthol + CamphorFixed-dose combination · cough-cold | Banned | S.O. 3371(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Naphazoline Nitrate + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Methyl Cellulose + Boric Acid + Menthol + CamphorFixed-dose combination · cough-cold | Banned | S.O. 3376(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Naphazoline HCl + Chlorpheniramine Maleate + Phenylephrine HCl + Menthol + CamphorFixed-dose combination · cough-cold | Banned | S.O. 3380(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Phenylephrine HCl + Naphazoline HCl + Menthol + Camphor + Hydroxy Propyl Methyl CelluloseFixed-dose combination · cough-cold | Banned | S.O. 3381(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Phenylephrine HCl + Naphazoline HCl + Menthol + CamphorFixed-dose combination · cough-cold | Banned | S.O. 3382(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Paracetamol + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3385(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Cetirizine HCl + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3386(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3387(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine + Phenylephrine HCl + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 3388(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Phenylephrine HCl + Paracetamol + Levocetirizine HCl + MentholFixed-dose combination · cough-cold | Banned | S.O. 3389(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Levo Cetirizine HCl + Ambroxol HCl + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3391(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ambroxol HCl + Phenylephrine HCl + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 3394(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Bromhexine HCl + Phenylephrine HClFixed-dose combination · cough-cold | Banned | S.O. 3395(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 2402(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Ibuprofen + Paracetamol + Phenylephrine + Chlorpheniramine MaleateFixed-dose combination · cough-cold | Banned | S.O. 253(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Phenylephrine + Chlorpheniramine Maleate + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 254(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4395(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Levocetirizine + Phenylephrine + ZincFixed-dose combination · cough-cold | Banned | S.O. 4522(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Loratadine + Phenylephrine + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4523(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Bromhexine + Phenylephrine + Chlorepheniramine MaleateFixed-dose combination · cough-cold | Banned | S.O. 4524(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4526(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Phenylephrine + Caffeine + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4527(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4530(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Zinc GluconateFixed-dose combination · cough-cold | Banned | S.O. 4533(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + MentholFixed-dose combination · cough-cold | Banned | S.O. 4534(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Ambroxol + Phenylephrine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4536(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Ambroxol + Guaifenesin + Ammonium Chloride + Phenylephrine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4538(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4539(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Triprolidine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4540(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Zinc Gluconate + MentholFixed-dose combination · cough-cold | Banned | S.O. 4542(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Bromhexine + Dextromethorphan + Phenylephrine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4545(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Phenylephrine + Ambroxol + Guaifenesin + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4548(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + MentholFixed-dose combination · cough-cold | Banned | S.O. 4549(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Dextromethorphan + Phenylephrine + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4552(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Phenylephrine + Dextromethorphan + MentholFixed-dose combination · cough-cold | Banned | S.O. 4556(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Triprolidine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4560(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pholcodine + Phenylephrine + PromethazineFixed-dose combination · cough-cold | Banned | S.O. 4562(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4564(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Dextromethorphan + MentholFixed-dose combination · cough-cold | Banned | S.O. 4565(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + TriprolidineFixed-dose combination · cough-cold | Banned | S.O. 4567(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol (Acetaminophen) + Loratadine + Ambroxol + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4568(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Paracetamol (Acetaminophen) + Dextromethorphan + Phenylephrine + Zinc GluconateFixed-dose combination · cough-cold | Banned | S.O. 4569(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4572(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 4574(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Acrivastine + Paracetamol + Caffeine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4576(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + PhenylephrineFixed-dose combination · eye | Banned | S.O. 4577(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4579(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Guaifenesin + TriprolidineFixed-dose combination · cough-cold | Banned | S.O. 4582(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ambroxol + Guaifenesin + Phenylephrine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4586(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Chlorpheniramine + Zinc GluconateFixed-dose combination · cough-cold | Banned | S.O. 4587(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4588(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Phenylephrine + Levocetirizine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4590(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + DiphenhydramineFixed-dose combination · cough-cold | Banned | S.O. 4592(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Nimesulide + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4601(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
Showing the 60 most recent of 156. The full list and CSV have the rest.
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
Top 30 of 51 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine Hydrochloride, Chlorpheniramine Maleate and Caffeine Tablets | Batch DRT25284Mfg Sep 2025 · Exp Aug 2027 | Eastern HealthcareUttarakhand | DescriptionDescription | RDTL, Bellary, KarnatakaState lab | Sep 2026 |
| Paracetamol, Phenylephrine Hydrochloride, Caffeine & Diphenhydramine Hydrochloride Tablets | Batch DHPLT/030725Mfg Jul 2025 · Exp Jun 2027 | Durgaji Healthcare Pvt.LtdUttarakhand | The sample does not conform to claim as per Schedule V, Drugs & Cosmetics Acts and rules 1945 with respect to test for 'Disintegration Time' and is also not of standard quality for the reason stated under 'Description'.Description | CDL, KolkataCDSCO lab | Sep 2026 |
| Paracetamol, Phenylephrine HCL, Chlorpheniramine Maleate, Sodium Citrate & Menthol Suspension | Batch SKL260238Mfg Mar 2026 · Exp Feb 2028 | S Kins PharmaHimachal Pradesh | The sample does not coform to the claim to the prescribed standard for Patent & Proprietary medicine with respect to the assay of menthol.Assay | Drug Testing Laboratory, Baddi, Solan, H.PState lab | Sep 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup | Batch 2601646Mfg Jan 2026 · Exp Dec 2027 | Saar Biotech Pvt. LtdHimachal Pradesh | content- Phenylephrine HydrochlorideOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Malete Syrup | Batch DPL-717Mfg Mar 2026 · Exp Feb 2028 | Dexbio Pharma Pvt LtdUttarakhand | content - Phenylephrine HydrochlorideOther | Drug Testing Laboratory, Madurai-19State lab | Sep 2026 |
| Paracetamol, Phenylephrine Hydrochloride, Caffeine & Diphenhydramine Hydrochloride Tablets | Batch GAB4135Mfg Dec 2025 · Exp Nov 2027 | Aagya Biotech Pvt. Ltd. 1.5 kmUttarakhand | The sample does not conforms to declared formula in respect of disintegration of tabletsDisintegration | LUCKNOW LABState lab | Aug 2026 |
| Dextromethorphan Hydrobromide Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup, | Batch JLJ2523Mfg Oct 2025 · Exp Sep 2027 | Janveda Healthceutical Pvt. LtdGujarat | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Phenylephrine HydrochlorideAssay | RDTL, ChandigarhCDSCO lab | Aug 2026 |
| Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets | Batch SBT-3351Mfg Jul 2025 · Exp Jun 2027 | Supercure Biotech Pvt. LtdHaryana | The sample is found to be Not of Standard Quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| PHENYLEPHRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE SYRUP IP | Batch XL260053Mfg Jan 2026 · Exp Dec 2027 | Xcell LabsHimachal Pradesh | pHpH | Govt Analyst PunjabState lab | Jul 2026 |
| Dextromethorphan HBr, Phenylephrine HCl & Chlorpheniramine Maleate Syrup). | Batch ABSL25-0183AMfg Oct 2025 · Exp Sep 2027 | Alexin BiosciencesHimachal Pradesh | MISBRANDED DRUGS.Misbranded | SFDTL UttarakhandState lab | Jul 2026 |
| Tinycold-AF Chlorpheniramine Maleate & Phenylephrine Hydrochloride Syrup IP | Batch AI.25089Mfg Jul 2025 · Exp Jun 2027 | Cian Healthcare Ltd. Kh.No. 248Uttarakhand | The content of phanylephrine Hydrochloride in the sample is less (i.e. 66.80% of the labelled amount) than IP limit (IP 90% to 110%)Labelling | FDAL, MumbaiState lab | Jun 2026 |
| Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup IP | Batch KKP-006Mfg Feb 2025 · Exp Jan 2027 | Park PharmaceuticalsHimachal Pradesh | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup | Batch OML24074Mfg Dec 2024 · Exp Nov 2026 | Omish Laboratories Pvt. LtdGujarat | Phenylephrine Hydrochloride ContentOther | FDL, VadodaraState lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hcl, Chlorpheniramine Maleate Syrup | Batch VDGS-483Mfg Sep 2025 · Exp Aug 2027 | Vzoic Healthcare Pvt. LtdPunjab | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Chlorpheniramine Maleate & Phenylephrine Hydrochloride Syrup | Batch S-199/25Mfg Jul 2025 · Exp Jun 2027 | Aban PharmaceuticalsKerala | Dextromethorphan Hydrobromide contentOther | FDL, VadodaraState lab | Jun 2026 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.