Home NDC 51316-421 Daytime Cold and Flu
Product NDC 51316-421
11-digit product format 513160421
Labeler code 51316
Product ID 51316-421_70d0e6d8-8206-4daa-b704-765e6d7f67a4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler CVS PHARMACY, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-31
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 mg/15mL; mg/15mL
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 Daytime Cold and Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
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 2604561 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 51316-421-12 Daytime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-421 DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) LIQUID [CVS PHARMACY, INC] 5 Current NDC, 1 package rows 20250316_1b8d5494-1fcf-4cd0-acc0-34f17d577bd7.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 74 of 180 · 3,583 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 51316-421-12 51316042112 355 mL in 1 BOTTLE, PLASTIC (51316-421-12) 355 ml 2024-05-31 No No Current