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.

35
Banned combinations in force
33
Other listed orders (stayed, restricted, quashed)
37
Batches failed a lab test
Jun 2026
Latest lab alert

Is it banned? Our answer pages

Not banned (LS/D) · old formulas banned

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 / combinationActionNotificationDateOrderStatus 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
Showing 15 of 37 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.