Home NDC 36800-580 Topcare Nite Time Day Time
Product NDC 36800-580
11-digit product format 368000580
Labeler code 36800
Product ID 36800-580_58aafd33-e288-483d-82c0-edd3ac369c60
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form KIT
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-29
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 Nite Time Day Time
Brand name suffix Cold and Flu
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 1086997 Internal RxNorm lookup 1094549 Internal RxNorm lookup 2634564 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 36800-143-73 Topcare Nite Time Day TimeCold and Flu 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 16 6.25 mg 7 36800-143-73 Topcare Nite Time Day TimeCold and Flu 8 in 1 CARTON CAPSULE, LIQUID FILLED 325 mg 7 36800-580-72 Topcare Nite Time Day TimeCold and Flu 1 in 1 CARTON KIT 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-580 TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 3 package rows 20241116_efb8e0e2-0795-4f4a-8ca6-955f33bee143.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 73 of 178 · 3,551 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 36800-143-73 36800014373 2 in 1 BLISTER PACK Historical 36800-580-72 36800058072 1 KIT in 1 CARTON (36800-580-72) * 8 BLISTER PACK in 1 CARTON (36800-143-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 kit 2014-04-29 0000-00-00 No No Current