Home NDC 51316-123 Cold and Flu
Product NDC 51316-123
11-digit product format 513160123
Labeler code 51316
Product ID 51316-123_e72b581b-6be6-4778-b995-d73c3f4a4757
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form KIT
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-28
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 Cold and Flu
Brand name suffix Daytime Nighttime
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 1043400 Internal RxNorm lookup 1113705 Internal RxNorm lookup 2637726 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 51316-120-02 Cold and FluDaytime Nighttime 355 mL in 1 BOTTLE, PLASTIC SOLUTION 355 mL 5 mg in 15mL 7 51316-123-02 Cold and FluDaytime Nighttime 1 in 1 PACKAGE KIT 1 7 51316-123-96 Cold and FluDaytime Nighttime 1 in 1 CARTON KIT 1 7 51316-130-02 Cold and FluDaytime Nighttime 355 mL in 1 BOTTLE, PLASTIC SOLUTION 355 mL 650 mg in 30mL 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-123 COLD AND FLU DAYTIME NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] 3 Current NDC, 4 package rows 20240627_dcb33d5f-87fa-4043-9b6d-36adec96796c.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 51316-120-02 51316012002 355 mL in 1 BOTTLE, PLASTIC 355 ml Historical 51316-123-02 51316012302 1 KIT in 1 PACKAGE (51316-123-02) * 355 mL in 1 BOTTLE, PLASTIC (51316-120-02) * 355 mL in 1 BOTTLE, PLASTIC (51316-130-02) 1 kit 2023-07-28 2028-03-31 No No Historical 51316-123-96 51316012396 1 KIT in 1 CARTON (51316-123-96) * 355 mL in 1 BOTTLE, PLASTIC (51316-120-02) * 355 mL in 1 BOTTLE, PLASTIC (51316-130-02) 1 kit 2023-07-28 No No Current 51316-130-02 51316013002 355 mL in 1 BOTTLE, PLASTIC 355 ml Historical