Home NDC 51316-527 Daytime Nighttime Severe Cold and Flu
Product NDC 51316-527
11-digit product format 513160527
Labeler code 51316
Product ID 51316-527_4d1d8a10-476d-1352-e063-6294a90a1279
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin, Doxylamine Succinate, Phenylephrine HCl
Dosage form KIT
Route ORAL
Labeler CVS HEALTH CORP
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 Daytime Nighttime Severe Cold and Flu
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 1297288 Internal RxNorm lookup 1656815 Internal RxNorm lookup 2634364 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 51316-527-24 Daytime Nighttime Severe Cold and Flu 2 in 1 CARTON KIT 2 3 51316-527-24 Daytime Nighttime Severe Cold and Flu 1 in 1 BLISTER PACK KIT 1 3 51316-527-48 Daytime Nighttime Severe Cold and Flu 4 in 1 CARTON KIT 4 3 51316-527-48 Daytime Nighttime Severe Cold and Flu 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 51316-527 DAYTIME NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS HEALTH CORP] 2 Current NDC, 4 package rows 20250429_23e2d2dc-12d4-294d-e063-6394a90a9523.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# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2634364 {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack GPCK 23e2d2dc-12d4-294d-e063-6394a90a9523 3 2634364 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack PSN 23e2d2dc-12d4-294d-e063-6394a90a9523 3 1297288 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule PSN 23e2d2dc-12d4-294d-e063-6394a90a9523 3 1656815 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule PSN 23e2d2dc-12d4-294d-e063-6394a90a9523 3 1297288 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 23e2d2dc-12d4-294d-e063-6394a90a9523 3 1656815 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 23e2d2dc-12d4-294d-e063-6394a90a9523 3 2634364 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack SY 23e2d2dc-12d4-294d-e063-6394a90a9523 3 1297288 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 23e2d2dc-12d4-294d-e063-6394a90a9523 3 1656815 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 23e2d2dc-12d4-294d-e063-6394a90a9523 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-527-24 51316052724 2 BLISTER PACK in 1 CARTON (51316-527-24) / 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 51316-527-48 51316052748 4 BLISTER PACK in 1 CARTON (51316-527-48) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK 4 blister pack 2025-02-01 No No Current