Home NDC 76162-903 Topcare DayTime NiteTime Cold and Flu Relief
Product NDC 76162-903
11-digit product format 761620903
Labeler code 76162
Product ID 76162-903_eeaf2e8c-7b55-46d3-82aa-cd871c2d5b67
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Dosage form KIT
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-27
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 Topcare DayTime NiteTime 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 1042675 Internal RxNorm lookup 2604561 Internal RxNorm lookup 2687211 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 76162-483-40 Topcare DayTime NiteTime Cold and Flu Relief 355 mL in 1 BOTTLE SOLUTION 355 mL 10 mg in 15mL 2 76162-599-40 Topcare DayTime NiteTime Cold and Flu Relief 355 mL in 1 BOTTLE SOLUTION 355 mL 10 mg in 15mL 2 76162-903-02 Topcare DayTime NiteTime Cold and Flu Relief 1 in 1 CARTON KIT 1 2
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 76162-483-40 76162048340 355 mL in 1 BOTTLE 355 ml Historical 76162-599-40 76162059940 355 mL in 1 BOTTLE 355 ml Historical 76162-903-02 76162090302 1 KIT in 1 CARTON (76162-903-02) * 355 mL in 1 BOTTLE (76162-599-40) * 355 mL in 1 BOTTLE (76162-483-40) 1 kit 2025-08-27 No No Current