Ingredient record · Mucus thinner for cough
Bromhexine: 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
68 entries containing Bromhexine are on India's banned-drugs list, and 35 are banned today. 37 batches of medicines containing Bromhexine failed a government lab test between October 2022 and June 2026, from 31 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
Bromhexine 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 |
|---|---|---|---|---|---|
| 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. |
| Salbutamol Sulphate + Bromhexine HCl + Guaifenesin + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Banned | S.O. 3402(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine MaleateFixed-dose combination · cough-cold | Banned | S.O. 3403(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Amoxicillin + BromhexineFixed-dose combination · antibiotics | Banned | S.O. 2395(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). |
| Ammonium Chloride + Bromhexine + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 2399(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). |
| Bromhexine + Dextromethorphan + Ammonium Chloride + MenthoFixed-dose combination · cough-cold | Banned | S.O. 2400(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). |
| 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). |
| Salbutamol + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 2403(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). |
| Salbutamol + Hydroxyethyltheophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 2407(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). |
| Salbutamol + Hydroxyethyl Theophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Under examination | S.O. 4687(E) | 7 September 2018 | 328 FDCs · Sep 2018 | SC order 14.02.2019: claimed pre-1988 FDC; under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 4#). Legally on sale pending examination. |
| 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 |
| Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4525(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethophen + Bromhexine + Chlorpheniramine Maleate + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4535(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 |
| Levofloxacin + BromhexineFixed-dose combination · antibiotics | Banned | S.O. 4546(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 |
| Terbutaline + Bromhexine + Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 4559(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 |
| Dextromethorphan + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4575(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 |
| Salbutamol + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4593(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Banned | S.O. 4595(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline + Bromhexine + EtofyllineFixed-dose combination · cough-cold | Banned | S.O. 4598(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Salbutamol + Theophylline + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 4618(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4631(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + Bromhexine + Chlorpheniramine + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4635(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Pseudoephedrine + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 4638(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Bromhexine + Cetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Banned | S.O. 4644(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as Enteric Coated Granules) 10000 S P UnitsFixed-dose combination · cough-cold | Banned | S.O. 4654(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Bromhexine + DextromethorphanFixed-dose combination · cough-cold | Banned | S.O. 4677(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Dextromethorphan + Chlorpheniramine + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 4678(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Albuterol + Etofylline + Bromhexine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4685(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Albuterol + Bromhexine + TheophyllineFixed-dose combination · cough-cold | Banned | S.O. 4686(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 |
| Bromhexine + Phenylephrine + Chlorpheniramine + ParacetamolFixed-dose combination · cough-cold | Banned | S.O. 4692(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4700(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + BromhexineFixed-dose combination · antibiotics | Under examination | S.O. 777(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Bromhexine + Phenylephrine + Chlorepheniramine MaleateFixed-dose combination · cough-cold | Quashed | S.O. 861(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 862(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethophen + Bromhexine + Chlorpheniramine Maleate + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 873(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Bromhexine + Dextromethorphan + Phenylephrine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 883(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Levofloxacin + BromhexineFixed-dose combination · antibiotics | Quashed | S.O. 884(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Diphenhydamine + Guaifenesin + Ammonium Chloride + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 889(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutaline + Bromhexine + Guaifenesin + DextromethorphanFixed-dose combination · cough-cold | Quashed | S.O. 897(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 |
| Dextromethorphan + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Quashed | S.O. 914(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ammomiumchloride + Bromhexine + DextromethorphanFixed-dose combination · cough-cold | Under examination | S.O. 922(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Bromhexine + Dextromethorphan + Ammonium Chloride + MentholFixed-dose combination · cough-cold | Under examination | S.O. 926(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| 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 |
| Salbutamol + Bromhexine + Guaifenesin + MentholFixed-dose combination · cough-cold | Quashed | S.O. 935(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Dextromethorphan + Bromhexine + GuaifenesinFixed-dose combination · cough-cold | Quashed | S.O. 937(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutaline + Bromhexine + EtofyllineFixed-dose combination · cough-cold | Quashed | S.O. 940(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Salbutamol + Thoephylline + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 961(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 974(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + GuaifenesinFixed-dose combination · cough-cold | Under examination | S.O. 977(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Salbutamoll + BromhexineFixed-dose combination · cough-cold | Under examination | S.O. 978(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Guaifenesin + Bromhexine + Chlorpheniramine + ParacetamolFixed-dose combination · cough-cold | Quashed | S.O. 980(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pseudoephedrine + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 984(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Bromhexine + Cetirizine + Phenylephrine + Guaifenesin + MentholFixed-dose combination · cough-cold | Quashed | S.O. 990(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as Enteric Coated granules)10000 SP UnitsFixed-dose combination · cough-cold | Quashed | S.O. 1000(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Showing the 60 most recent of 68. 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.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesin & Menthol Syrup | EM1LF005Mfg 2025-04 · Exp 2027-03 | Unicure India LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Terbutaline Sulphate, Bromhexine HCl, Guaiphenesin & Menthol Syrup | M24317Mfg 2024-12 · Exp 2026-11 | Healcure LifesciencesHimachal Pradesh | Assay for Bromhexine Hydrochloride and Description as per Schedule V of Drugs and Cosmetics Act 1940 & Rules 1945 thereunderAssay | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | L-2601029Mfg 2026-01 · Exp 2027-12 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine Hydrochloride.Assay | RDTL, ChandigarhCDSCO lab | Jun 2026 |
| Terbutaline Sulphate, Bromhexine Hydrochloride Guaiphenesin & Menthol Syrup | ULD014Mfg 2025-04 · Exp 2027-03 | Haustus Biotech Pvt. Ltd. 44-45 | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Terbutaline Sulphate, Bromhexine HCL, Guaiphenesin & Menthol Syrup | AL25061Mfg 2025-06 · Exp 2027-05 | Cian Healthcare LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | May 2026 |
| Bromhexine Hydrochloride,Terbutaline Sulphate,Guaiphenesin & Menthol Syrup | R02GL2529Mfg 2025-01 · Exp 2026-12 | Rednex Pharmaceuticals Pvt. LtdKerala | The sample does not conform to claim as per Manufacturer method & specification in respect to the Assay of MentholAssay | CDL, KolkataCDSCO lab | Apr 2026 |
| Salbutamol Sulphate, I.P (Equivalent to salbutamol) -2mg Bromhexine Hydrochloride, IP-4mg Guaiphenesin, IP-100mg Menthol, IP-1mg | PL-182Mfg 2025-09 · Exp 2027-08 | Panacea LaboratoriesWest Bengal | The sample does not conform to manufacturers specification with respect to the Assay of Bromhexine Hydrochloride.Assay | CDL, KolkataCDSCO lab | Mar 2026 |
| Terbutaline Sulphate, Bromhexine Hydrochloride, Guiaphenesin & Menthol Syrup | EM1LF002Mfg 2025-04 · Exp 2027-03 | Unicure India LtdUttarakhand | ContentOther | Drugs Testing Laboratory, Madurai-19State lab | Jan 2026 |
| Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesin & Menthol Syrup | LXB-003Mfg 2025-08 · Exp 2027-07 | Bindlysh Biotec LtdDelhi | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine HydrochlorideAssay | RDTL, ChandigarhCDSCO lab | Jan 2026 |
| Terbutaline Sulphate, Bromhexine Hcl, Guaiphenesin Syrup | D240694Mfg 2024-09 · Exp 2026-08 | Dr.Reddy's Laboratories LimitedHimachal Pradesh | ContentOther | Drugs Testing Laboratory, Madurai-19State lab | Jan 2026 |
| Terbutaline Sulphate, Bromhexine HCl, Guaiphenesin & Menthol Syrup, | LPS-2510209Mfg 2025-10 · Exp 2027-09 | Lapan Healthcare Pvt. LtdHaryana | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Terbutaline Sulphate, Bromhexine HydrochlorideAssay | RDTL, ChandigarhCDSCO lab | Jan 2026 |
| Enrofloxacin & Bromhexine HCL Oral Solution (Quinrox-BH Antibacterial & Mucolytic For Veterinary Use) | QXB0525Mfg 2025-06 · Exp 2027-05 | Indovet Life Sciences Pvt. LtdTelangana | DescriptionDescription | RDTL, Bellary, KarnatakaState lab | Jan 2026 |
| Bromhexine Hydrochloride, Terbutaline Sulphate & Guaiphenesin & Menthol Syrup | EL24113Mfg 2024-02 · Exp 2026-01 | Edkem Pharmaceuticals Ltd.M9-M12. GallopsGujarat | The sample does not conform to claim as per Schedule V, Drugs & Cosmetics Act in respect to the Assay of MentholAssay | CDL, KolkataCDSCO lab | Jan 2026 |
| Bromhexine Hydrochloride Syrup-4mg/5ml | BHS24002Mfg 2024-03 · Exp 2027-02 | Galpha Laboratories LimitedHimachal Pradesh | ContentOther | Drugs Testing Laboratory, Madurai-19State lab | Jan 2026 |
| Bromhexine Hydrochloride,Terbutaline Sulphate,Guaiphenesin & Menthol Syrup | R12GL2424Mfg 2024-12 · Exp 2026-11 | Rednex Pharmaceuticals Pvt. LtdKerala | The sample does not conform to claim as per Schedule V, Drugs & Cosmetics Act in respect to the Assay of MentholAssay | CDL, KolkataCDSCO lab | Jan 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.