Home NDC 16103-381 PHARBINEX-DM
Product NDC 16103-381
11-digit product format 161030381
Labeler code 16103
Product ID 16103-381_fcbabd90-abc6-4a05-8841-58cb74b5a22e
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN 400mg and DEXTROMETHORPHAN HBR 20MG
Dosage form TABLET
Route ORAL
Labeler Pharbest Pharmaceuticals, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-02
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 400; 20 mg/1; mg/1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 16103-381-04 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16103-381-04 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16103-381-04 bd6a592717d7…303034d00443…
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 PHARBINEX-DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147685 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16103-381-04 PHARBINEX-DM 30 in 1 BOTTLE, PLASTIC TABLET 30 3 16103-381-04 PHARBINEX-DM 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16103-381 PHARBINEX-DM (GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG) TABLET [PHARBEST PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240120_8d71db43-da87-45ee-aa4a-7e870bc5016d.zip
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 Marketing start Marketing end Sample Exclude flag Status 16103-381-04 16103038104 1 BOTTLE, PLASTIC in 1 CARTON (16103-381-04) / 30 TABLET in 1 BOTTLE, PLASTIC 2018-04-02 0000-00-00 No No Current