Home NDC 21130-940 Nighttime cold and flu relief
Product NDC 21130-940
11-digit product format 211300940
Labeler code 21130
Product ID 21130-940_2df15421-7212-0301-e063-6394a90a067b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler BETTER LIVING BRANDS LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-10
Substance DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 6.25; 325; 15 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 21130-940-24 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 21130-940-24 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 21130-940-24 0efc9e666f02…f202fb6c5f17…
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 Nighttime cold and flu relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 6.25 mg/1 ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9BI9B5YI2 Internal UNII lookup 362O9ITL9D 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 1094549 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 21130-940-24 Nighttime cold and flu relief 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3 21130-940-24 Nighttime cold and flu relief 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-940 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [BETTER LIVING BRANDS LLC.] 3 Current NDC, 2 package rows 20250214_f2c01090-645c-1efe-e053-2995a90a7df5.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 Units Marketing start Sample Exclude flag Status 21130-940-24 21130094024 2 BLISTER PACK in 1 CARTON (21130-940-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2023-07-10 No No Current