Ingredient record · Antihistamine in cough syrups
Diphenhydramine: 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
13 entries containing Diphenhydramine are on India's banned-drugs list, and 8 are banned today. 22 batches of medicines containing Diphenhydramine failed a government lab test between December 2020 and September 2026, from 18 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
8
Banned combinations in force
5
Other listed orders (stayed, restricted, quashed)
22
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned
Advanced on sale · Extra withdrawn (2016)
On the banned-drugs list
Diphenhydramine 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 |
|---|---|---|---|---|---|
| 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 |
| Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + CamphorFixed-dose combination · skin | Banned | S.O. 3312(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Menthol + Lignocaine HCl + Aloe Vera Gel + Clotrimazole + DiphenhydramineFixed-dose combination · skin | Banned | S.O. 3325(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 4529(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diphenhydramine + Guaifenesin + Ammonium Chloride + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 4551(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 4570(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 |
| Guaifenesin + Diphenhydramine + Bromhexine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4690(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + MentholFixed-dose combination · cough-cold | Quashed | S.O. 866(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Quashed | S.O. 908(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + DiphenhydramineFixed-dose combination · cough-cold | Quashed | S.O. 934(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Guaifenesin + Diphenhydramine + Bromhexine + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 1037(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diazepam and Diphenhydramine HydrochlorideFixed-dose combination · cough-cold | Banned | GSR 169(E) | 12 March 2001 | Classic bans | In force per CDSCO consumer list (1983-2017) |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| 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 Phenylepherine Hydrochloride Caffine (Anhydrous) Diphenhydramine Hydrochloride | Batch T-2511129Mfg Nov 2025 · Exp Oct 2027 | Aagya Biotech Pvt. Ltd. 1.5 kmUttarakhand | DescriptionDescription | SDT&RL, BhubanesearState lab | Sep 2026 |
| Diphenhydramine HCl, Ammonium Chloride, Sodium Citrate and Menthol Syrup 50 ml | Batch 26007Mfg Feb 2026 · Exp Jan 2028 | Riemann Labs Pvt. LtdMadhya Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of MentholAssay | RDTL, ChandigarhCDSCO 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 |
| Paracetamol, Phenylephrine Hydrochloride Diphenhydramine, Hydrocloride & Caffeine Tablets | Batch YLT25023Mfg Jun 2025 · Exp May 2027 | YL PharmaHimachal Pradesh | The sample does not conform to the claim with respect to in Assay of Phenylephrine Hydrochloride & Caffeine (Anhydrous) (NIL).Assay | DTL JaipurState lab | Feb 2026 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate and Terpin Hydrate Syrup | Batch B46826001Mfg Jan 2026 · Exp Dec 2027 | Torque Phamrmaceuticals Pvt. Ltd.13B-14 | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate.Assay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | Batch S285011Mfg Apr 2025 · Exp Mar 2027 | Goa Antibiotics & Pharmaceuticals LtdGoa | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate.Assay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | Batch 2519031L002Mfg Dec 2025 · Exp Nov 2027 | Scott-Edil Pharmacia LtdHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate.Assay | RDTL, ChandigarhCDSCO lab | Feb 2026 |
| Diphenhydramine HCl, Ammonium Chloride, Sodium Citrate & Menthol Syrup | Batch ZRSL - 1806Mfg Sep 2025 · Exp Aug 2027 | ZRS Pharmaceuticals India Pvt. LtdHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate and Menthol.Assay | RDTL, ChandigarhCDSCO lab | Jan 2026 |
| Paracetamol, Phenylephrine Hcl, Caffeine & Diphenhydramine Hcl Tablets | Batch YLT25006Mfg Jan 2025 · Exp Dec 2026 | YL PharmaHimachal Pradesh | Identification & AssayAssay | DTL ,Baddi, HPState lab | Sep 2025 |
| Diphenhydramine Hydrochloride Capsules IP 25 mg | Batch C 364Mfg Feb 2024 · Exp Jan 2026 | Bittu Pharmaceuticals (II)Maharashtra | DissolutionDissolution | State Lab KarnatakaState lab | Jun 2025 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) | Batch 40183Mfg Feb 2024 · Exp Jan 2026 | Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh | Assay of Menthol and DescriptionAssay | CDL KolkataCDSCO lab | Dec 2024 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) | Batch 40186Mfg Feb 2024 · Exp Jan 2026 | Zenith Drugs Ltd. 72/5 & 72/3Madhya Pradesh | Assay of Menthol and DescriptionAssay | CDL KolkataCDSCO lab | Dec 2024 |
| Diphenhydramine Hydrochloride Capsules IP (XL Dryl-D Capsules) | Batch CPD240100 6Mfg Jan 2024 · Exp Dec 2025 | Caspian PharmaceuticalsHimachal Pradesh | Dissolution and Assay of Diphenhydramin e HydrochlorideAssay | RDTL ChandigarhCDSCO lab | Apr 2024 |
| Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup | Batch ML220730Mfg Dec 2022 · Exp Nov 2024 | Mascot Health Series Pvt. LtdUttarakhand | Assay/content of MentholAssay | CDL KolkataCDSCO lab | Nov 2023 |
Showing 15 of 22 records
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.