Home NDC 51316-499 Night Time Cough
Product NDC 51316-499
11-digit product format 513160499
Labeler code 51316
Product ID 51316-499_1759e963-dc81-4abe-96d7-37c8a35f7d9d
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler CVS PHARMACY, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-15
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 30; 12.5 mg/30mL; mg/30mL
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 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 Night Time Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234386 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 51316-499-12 Night Time Cough 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-499 NIGHT TIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [CVS PHARMACY, INC] 2 Current NDC, 1 package rows 20240316_97aa0b90-1230-4143-b5d3-18b96a6b7b4f.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 51316-499-12 51316049912 355 mL in 1 BOTTLE, PLASTIC (51316-499-12) 355 ml 2023-03-15 No No Current