Home NDC 76162-417 TOPCARE HONEY FLAVOR COLD AND FLU RELIEF
Product NDC 76162-417
11-digit product format 761620417
Labeler code 76162
Product ID 76162-417_2256623c-7642-4c39-b022-bfaecc861f1c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride
Dosage form KIT
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-06
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 HONEY FLAVOR 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 1369842 Internal RxNorm lookup 1431245 Internal RxNorm lookup 2637731 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 76162-202-40 TOPCARE HONEY FLAVOR COLD AND FLU RELIEF 355 mL in 1 BOTTLE SOLUTION 355 mL 6.25 mg in 15mL 1 76162-417-02 TOPCARE HONEY FLAVOR COLD AND FLU RELIEF 1 in 1 CARTON KIT 1 1 76162-500-40 TOPCARE HONEY FLAVOR COLD AND FLU RELIEF 355 mL in 1 BOTTLE SOLUTION 355 mL 5 mg in 15mL 1
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 2637731 {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack GPCK 2256623c-7642-4c39-b022-bfaecc861f1c 1 2637731 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack PSN 2256623c-7642-4c39-b022-bfaecc861f1c 1 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution PSN 2256623c-7642-4c39-b022-bfaecc861f1c 1 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution PSN 2256623c-7642-4c39-b022-bfaecc861f1c 1 1431245 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD 2256623c-7642-4c39-b022-bfaecc861f1c 1 1369842 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD 2256623c-7642-4c39-b022-bfaecc861f1c 1 2637731 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack SY 2256623c-7642-4c39-b022-bfaecc861f1c 1 1431245 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 2256623c-7642-4c39-b022-bfaecc861f1c 1 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 2256623c-7642-4c39-b022-bfaecc861f1c 1 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 2256623c-7642-4c39-b022-bfaecc861f1c 1 1369842 acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 2256623c-7642-4c39-b022-bfaecc861f1c 1 1431245 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY 2256623c-7642-4c39-b022-bfaecc861f1c 1 1369842 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY 2256623c-7642-4c39-b022-bfaecc861f1c 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76162-202-40 76162020240 355 mL in 1 BOTTLE 355 ml Historical 76162-417-02 76162041702 1 KIT in 1 CARTON (76162-417-02) * 355 mL in 1 BOTTLE (76162-202-40) * 355 mL in 1 BOTTLE (76162-500-40) 1 kit 2025-08-06 No No Current 76162-500-40 76162050040 355 mL in 1 BOTTLE 355 ml Historical