Home NDC 51316-547 Ultra concentrated Daytime/ Nighttime Severe Softgel
Product NDC 51316-547
11-digit product format 513160547
Labeler code 51316
Product ID 51316-547_4de9aabc-fafa-fd37-e063-6294a90ab10c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine hydrochloride softgel
Dosage form KIT
Route ORAL
Labeler CVS PHARMACY, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-01
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 Ultra concentrated Daytime/ Nighttime Severe Softgel
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 1086997 Internal RxNorm lookup 1297288 Internal RxNorm lookup 2634363 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 51316-547-24 Ultra concentrated Daytime/ Nighttime Severe Softgel 2 in 1 CARTON KIT 2 3 51316-547-24 Ultra concentrated Daytime/ Nighttime Severe Softgel 1 in 1 BLISTER PACK KIT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-547 ULTRA CONCENTRATED DAYTIME/ NIGHTTIME SEVERE SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL) KIT [CVS PHARMACY, INC] 2 Current NDC, 2 package rows 20250429_24cedaec-06a6-8fde-e063-6394a90a3d7a.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 51316-547-24 51316054724 2 BLISTER PACK in 1 CARTON (51316-547-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK 2 blister pack 2025-02-01 No No Current