Home NDC 51316-081 CVS Dex-Dox Kids Nighttime Cough Suppressant
Product NDC 51316-081
11-digit product format 513160081
Labeler code 51316
Product ID 51316-081_2f8b6f5e-399d-b033-e063-6294a90ac3d1
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form CHEWABLE GEL
Route ORAL
Labeler CVS
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-04
Substance DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 6.25; 10 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 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 Dex-Dox Kids Nighttime Cough Suppressant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 6.25 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 V9BI9B5YI2 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 2683423 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 51316-081-16 CVS Dex-Dox Kids Nighttime Cough Suppressant 16 in 1 BOTTLE CHEWABLE GEL 16 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-081 CVS DEX-DOX KIDS NIGHTTIME COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) CHEWABLE GEL [CVS] 1 Current NDC, 1 package rows 20250308_2f8b6f5e-399c-b033-e063-6294a90ac3d1.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 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 51316-081-16 51316008116 16 CHEWABLE GEL in 1 BOTTLE (51316-081-16) 16 chewable gel 2025-03-04 No No Current