Home NDC 36800-143 topcare nite time cold and flu
Product NDC 36800-143
11-digit product format 368000143
Labeler code 36800
Product ID 36800-143_77dfcc34-4ae3-4910-b469-19d84ddd71c4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-02-02
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-143 36800-143-73 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 cold and flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 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 36800-143-62 topcare nite time cold and flu 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 8 36800-143-62 topcare nite time cold and flu 12 in 1 CARTON CAPSULE, LIQUID FILLED 12 8 36800-143-73 topcare nite time cold and flu 8 in 1 CARTON CAPSULE, LIQUID FILLED 8 8 36800-143-73 topcare nite time cold and flu 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 8 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
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 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [TOPCO ASSOCIATES LLC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [TOPCO ASSOCIATES LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 GELATIN INACTIVE INGREDIENT 2G86QN327L TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [TOPCO ASSOCIATES LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [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 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [TOPCO ASSOCIATES LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-143 TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 4 package rows 20241017_516ab016-31f9-4829-8b94-2f968933093c.zip 36800-143 TOPCARE NITE TIME DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC 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 68 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate SF Menthol Cough Drops MENTHOL WalMart 003a229c-b014-e9f3-e063-6294a90aa5ed 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 Warnings Exact identifier application number: M012
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 36800-143-62 36800014362 12 BLISTER PACK in 1 CARTON (36800-143-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 12 blister pack 2014-02-02 0000-00-00 No No Current 36800-143-73 36800014373 8 BLISTER PACK in 1 CARTON (36800-143-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 8 blister pack 2014-02-14 0000-00-00 No No Current