NDC 51316-604 - Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 51316-604
Package NDCs from labels: 51316-604-05
Manufacturer: CVS Pharmacy, Inc
Effective date: 2025-10-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Acetaminophen, Dextromethorphan HBr - CVS Pharmacy, Inc	CVS Pharmacy, Inc	2025-10-21	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-604-05	Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate	6 in 1 PACKET	POWDER	6 in 12	30 mg	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-604	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE KIT [CVS PHARMACY, INC]	1	Unmatched	20240410_1532ee21-e114-ded7-e063-6294a90ab025.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 273 of 332 · 6,623 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Chest Congestion DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreens	e4515d0e-c12b-40cd-8218-6d91476cfebd	2024-06-21	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	9e4024f4-0f60-dfef-e053-2995a90ac366	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
SUDOGEST	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	1811199f-bf88-475f-8f94-b372db4bead3	2024-06-20	Warnings	Exact identifier application number: M012
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	925f9787-3d1c-0189-e053-2a95a90a2972	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier unii: 362O9ITL9D
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier unii: 362O9ITL9D
Theraflu Severe Cold Relief Soft Chews	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	91dbb541-6a86-4803-a1fe-1bf61b457c34	2024-06-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	8c2a7a68-5a84-c909-e053-2995a90ad5b6	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	8f12016d-904f-00b4-e053-2a95a90ad02a	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier unii: 362O9ITL9D
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	NuCare Pharmaceuticals,Inc.	80c9a58d-98ae-5497-e053-2991aa0a61fb	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	8592e901-9353-6fb6-e053-2a91aa0ad33b	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	86be8920-2f35-fbc3-e053-2991aa0a0015	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	872365ca-0c6b-550a-e053-2a91aa0ab25a	2024-06-14	Warnings	Exact identifier unii: 362O9ITL9D
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	Warnings	Exact identifier unii: 362O9ITL9D
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier unii: 362O9ITL9D
Migraine Relief	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	a6a07615-3108-436f-bbce-be7cb89ce456	2024-06-13	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.