Home NDC 85722-0002 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Product NDC 85722-0002
11-digit product format 857220002
Labeler code 85722
Product ID 85722-0002_9cb5da4e-9175-4339-83da-fc22448b2e80
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form SYRUP
Route ORAL
Labeler KJD Pharma Private Limited
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 300 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL GUAIFENESIN 300 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1117394 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85722-0002-4 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 118 mL in 1 BOTTLE SYRUP 118 2 85722-0002-6 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 473 mL in 1 BOTTLE SYRUP 473 2 85722-0002-8 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 236 mL in 1 BOTTLE SYRUP 236 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 118 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join daytime severe cold multi-symptom ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL United Natural Foods, Inc. dba UNFI cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd 2025-03-08 Warnings Exact identifier application number: M012 Cold and Head Congestion Relief Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL WinCo Foods, LLC a39778ba-1f63-4495-8e9b-44b0bdd7f71a 2025-03-08 Warnings Exact identifier application number: M012 Extra Strength TYLENOL Severe Cough Plus Sore Throat Day ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE Kenvue Brands LLC 2e9540e4-bd1d-9370-e063-6294a90affcb 2025-03-07 Warnings Exact identifier application number: M012 Herbal Cough Drops Original Herb COUGH DROPS Topco Associates LLC 2fb22181-aee3-d0bf-e063-6294a90a7865 2025-03-06 Warnings Exact identifier application number: M012 REVASOL DAYTIME COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE Rnv LLC 2f9ddcc3-b913-f8b0-e063-6294a90a93ab 2025-03-05 Warnings Exact identifier application number: M012 Herbal Throat Drops Lemon Mint Herb THROAT DROPS Topco Associates LLC 2fa086b4-3b0e-0df8-e063-6294a90a6769 2025-03-05 Warnings Exact identifier application number: M012 Redicare Nasal and Sinus Decongestant REDICARE NASAL AND SINUS DECONGESTANT Redicare LLC 2f24be68-f30e-d916-e063-6294a90a7e31 2025-03-04 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HCL ORAL SOLUTION Kesin Pharma Corporation 2f871005-de4d-8b2a-e063-6394a90aa43a 2025-03-04 Warnings Exact identifier application number: M012 CVS Daytime Cough Relief Chews - Citrus Punch DEXTROMETHORPHAN HBR CVS 2f885f1b-7ff5-251b-e063-6394a90a656f 2025-03-04 Warnings Exact identifier application number: M012 CVS Dex-Dox Kids Nighttime Cough Suppressant DEXTROMETHORPHAN HBR CVS 2f8b6f5e-399c-b033-e063-6294a90ac3d1 2025-03-04 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ff8b096c-8f01-4a8c-a98f-e4aa4d688e95 2025-03-04 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL 7-ELEVEN 2f3c43dd-175f-722e-e063-6294a90acff9 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN 7-ELEVEN 2f3c3c65-4178-6304-e063-6294a90a51fa 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 2025-02-25 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efc46c9-a421-1998-e063-6394a90aeb64 2025-02-25 Warnings Exact identifier application number: M012 Redicare Cough Drops Cherry Flavored CHERRY FLAVORED MENTHOL COUGH DROPS Redicare LLC 2efeaafa-ee96-37ee-e063-6394a90a9a4b 2025-02-25 Warnings Exact identifier application number: M012 Childrens Allergy DIPHENHYDRAMINE HCL Genexa Inc. e880b8d7-61c3-41cc-e053-2995a90aaaeb 2025-02-20 Warnings Exact identifier application number: M012 Gencare-Nasal Decongestant PE PHENYLEPHRINE HYDROCHLORIDE Pioneer Life Sciences, LLC 596ec923-56a0-4b6e-a69c-8d740feb75a2 2025-02-20 Warnings Exact identifier application number: M012 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Kenvue Brands LLC 77a2dc96-73ee-4ca2-b1fe-406995802606 2025-02-19 Warnings Exact identifier application number: M012 nasal decongestant OXYMETAZOLINE HYDROCHLORIDE Safeway f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2 2025-02-19 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85722-0002-4 85722000204 118 mL in 1 BOTTLE (85722-0002-4) 118 ml 2021-02-01 No No Current 85722-0002-6 85722000206 473 mL in 1 BOTTLE (85722-0002-6) 473 ml 2021-02-01 No No Current 85722-0002-8 85722000208 236 mL in 1 BOTTLE (85722-0002-8) 236 ml 2021-02-01 No No Current