Home NDC 51316-635 CVS PHARMACY
Product NDC 51316-635
11-digit product format 513160635
Labeler code 51316
Product ID 51316-635_18c65cf1-b3d8-4764-8b5d-d77ea642df5d
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine maleate,Dextromethorphan HBr,Diphenhydramine HCl
Dosage form KIT
Labeler CVS PHARMACY, INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-03
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 CVS PHARMACY
Brand name suffix COLD and COUGH And NIGHTTIME VALUE PACK
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049884 Internal RxNorm lookup 2683421 Internal RxNorm lookup 2683422 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 51316-632-04 CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 mL 2 mg in 10mL 2 51316-635-08 CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK 1 in 1 KIT KIT 1 2 51316-646-04 CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 mL 12.5 mg in 10mL 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-635 CVS PHARMACY COLD AND COUGH AND NIGHTTIME VALUE PACK (BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL) KIT [CVS PHARMACY, INC.] 1 Current NDC, 3 package rows 20250322_4d94968b-ada3-4344-8563-cba7fc491d74.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 51316-632-04 51316063204 118 mL in 1 BOTTLE, PLASTIC 118 ml Historical 51316-635-08 51316063508 1 KIT in 1 KIT (51316-635-08) * 118 mL in 1 BOTTLE, PLASTIC (51316-632-04) * 118 mL in 1 BOTTLE, PLASTIC (51316-646-04) 1 kit 2025-03-03 No No Current 51316-646-04 51316064604 118 mL in 1 BOTTLE, PLASTIC 118 ml Historical