Home NDC 51316-803 Pain, Headache and Cough
Product NDC 51316-803
11-digit product format 513160803
Labeler code 51316
Product ID 51316-803_9d0ed71c-c1ac-498d-8174-98c687cc5696
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-21
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 mg/1; mg/1
Pharmacologic classes 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 2027-12-31
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 Pain, Headache and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 2709673 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 51316-803-09 Pain, Headache and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 51316-803-09 Pain, Headache and Cough 2 in 1 CARTON TABLET, FILM COATED 2 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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-803-09 51316080309 2 BLISTER PACK in 1 CARTON (51316-803-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2026-04-21 No No Current