Home NDC 51316-647 Daytime, Nighttime Severe Cold and Flu Relief
Product NDC 51316-647
11-digit product format 513160647
Labeler code 51316
Product ID 51316-647_d541ff04-1e02-4090-b22b-6417da4e3b39
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl
Dosage form KIT
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-03
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 Daytime, Nighttime Severe Cold and Flu Relief
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1110988 Internal RxNorm lookup 1546881 Internal RxNorm lookup 2634817 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 51316-647-22 Daytime, Nighttime Severe Cold and Flu Relief 1 in 1 CARTON KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-647 DAYTIME, NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] 3 Current NDC, Legacy NDC, 1 package rows 20241121_c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159.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 2634817 {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack GPCK c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 2634817 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack PSN c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 1546881 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet PSN c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 1110988 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet PSN c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 1546881 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 1110988 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 2634817 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack SY c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 1546881 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet SY c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4 1110988 APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51316-647-22 51316064722 1 KIT in 1 CARTON (51316-647-22) * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2022-11-03 0000-00-00 No No Current