Home NDC 51316-778 Long Acting Cough Softgels
Product NDC 51316-778
11-digit product format 513160778
Labeler code 51316
Product ID 51316-778_4b8ebd3f-db86-42c1-965a-29beb175c620
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler CVS PHARMACY, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-28
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 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 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 Long Acting Cough Softgels
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1090487 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 51316-778-23 Long Acting Cough Softgels 20 in 1 BOTTLE CAPSULE, LIQUID FILLED 20 4 51316-778-23 Long Acting Cough Softgels 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-778 LONG ACTING COUGH SOFTGELS (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC] 4 Current NDC, Legacy NDC, 2 package rows 20250106_322daee6-c61d-43d3-a54d-a354fd3df242.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 Marketing end Sample Exclude flag Status 51316-778-23 51316077823 1 BOTTLE in 1 CARTON (51316-778-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2021-07-28 0000-00-00 No No Current