Ingredient record · Nasal decongestant
Phenylephrine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
156 entries containing Phenylephrine are on India's banned-drugs list, and 84 are banned today. 115 batches of medicines containing Phenylephrine failed a government lab test between March 2020 and July 2026, from 90 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)under verification | 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 (gazette egazette.gov.in/WriteReadData/2026/275640.pdf not fetchable from build environment), being verified |
| Chlorpheniramine Maleate + Phenylephrine Hydrochloride (children below 4 years)Fixed-dose combination · cough-cold | Restricted | S.O. 1717(E)under verification | 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, being verified |
| 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 50 products by number of batches.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Paracetamol, Phenylephrine HCL, Guaiphenesin, Cetirizine Hydrochloride & Ambroxol HCL Tablets | SBT-3351Mfg 2025-07 · Exp 2027-06 | 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 | XL260053Mfg 2026-01 · Exp 2027-12 | Xcell LabsHimachal Pradesh | pHpH | Govt Analyst PunjabState lab | Jul 2026 |
| Dextromethorphan HBr, Phenylephrine HCl & Chlorpheniramine Maleate Syrup). | ABSL25-0183AMfg 2025-10 · Exp 2027-09 | Alexin BiosciencesHimachal Pradesh | MISBRANDED DRUGS.Misbranded | SFDTL UttarakhandState lab | Jul 2026 |
| Tinycold-AF Chlorpheniramine Maleate & Phenylephrine Hydrochloride Syrup IP | AI.25089Mfg 2025-07 · Exp 2027-06 | 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 | KKP-006Mfg 2025-02 · Exp 2027-01 | Park PharmaceuticalsHimachal Pradesh | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup | OML24074Mfg 2024-12 · Exp 2026-11 | Omish Laboratories Pvt. LtdGujarat | Phenylephrine Hydrochloride ContentOther | FDL, VadodaraState lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Phenylephrine Hcl, Chlorpheniramine Maleate Syrup | VDGS-483Mfg 2025-09 · Exp 2027-08 | Vzoic Healthcare Pvt. LtdPunjab | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Dextromethorphan Hydrobromide, Chlorpheniramine Maleate & Phenylephrine Hydrochloride Syrup | S-199/25Mfg 2025-07 · Exp 2027-06 | Aban PharmaceuticalsKerala | Dextromethorphan Hydrobromide contentOther | FDL, VadodaraState lab | Jun 2026 |
| Paracetamol, Phenylephrine HCL, Caffeine and Disphenhydramine HCL Tablets | UT-250656DMfg 2025-05 · Exp 2027-04 | Ultra Drugs Pvt. Ltd. (Unit-II) HS No. 211Himachal Pradesh | The sample fails in the Test for Description and DisintegrationDescription | MDTL KathuaState lab | May 2026 |
| Dextromethorphan Hydrobromide,Ambroxol Hydrochloride,Chlorpheniramine Maleate , Phenylephrine Hydrochloride & Menthol Syrup | CLRA4004Mfg 2024-12 · Exp 2026-11 | Crest Lifesciences Pvt. LtdHimachal Pradesh | The sample does not conform to claim with respect to Assay of Phenylephrine Hydrochloride, Ambroxol Hydrochloride and MentholAssay | CDL, KolkataCDSCO lab | May 2026 |
| Dextromethorphan HBr, Phenylephrine HCl & Chlorpheniramine Maleate Softgel Capsules). | BSG251314CMfg 2025-09 · Exp 2027-08 | Bionexy PharmaHimachal Pradesh | Assay of Dextromethorphan HBr IP- Less than prescribed Limit.Assay | SDTL, UttarakhandState lab | May 2026 |
| Aceclofenac, Paracetamol, Phenylephrine Hcl Cetirizine Hcl & Caffeine | GT-25294AMfg 2025-08 · Exp 2028-07 | Not applicable | MisbrandadMisbranded | SDTL, ChhattisgarhState lab | May 2026 |
| Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Suspension125mg/5mg/1mg (60ml) | PRL2501-03Mfg 2025-01 · Exp 2026-12 | Regent Ajanta BiotechUttarakhand | The sample received does not conform to Manufacturers specification with respect to the test for Description and Assay of Phenyleprhine hydrochloride.Assay | CDTL, MumbaiCDSCO lab | Apr 2026 |
| Dextromethorphan hydrobromide, phenylephrine hydrochloride & Chlorpheniramine Maleate Syrup | L 24371Mfg 2024-11 · Exp 2026-10 | KNM Pharma Pvt. LtdGujarat | Microbial Contamination (Total Aerobic Viable Count)Microbial limits | FDL, VadodaraState lab | Apr 2026 |
| Dextromethorphan hydrobromide, phenylephrine hydrochloride & Chlorpheniramine Maleate Syrup | L 24326Mfg 2024-11 · Exp 2026-10 | KNM Pharma Pvt. LtdGujarat | Microbial Contamination (Total Aerobic Viable Count)Microbial limits | FDL, VadodaraState lab | Apr 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.