Home NDC 36800-540 TopCare Daytime Severe Cold and Cough
Product NDC 36800-540
11-digit product format 368000540
Labeler code 36800
Product ID 36800-540_24ff6c4a-adc0-4e85-837b-b84398d2b133
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler TOPCARE (Topco Associates LLC)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-03-18
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-540-06 TopCare Daytime Severe Cold and CoughBerry infused with Menthol and Green Tea flavors 6 in 1 BOX GRANULE, FOR SOLUTION 6 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Acetaminophen ACTIVE MOIETY 362O9ITL9D TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Acesulfame INACTIVE INGREDIENT MA3UYZ6K1H TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Aspartame INACTIVE INGREDIENT Z0H242BBR1 TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Maltodextrin INACTIVE INGREDIENT 7CVR7L4A2D TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Sucrose INACTIVE INGREDIENT C151H8M554 TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-540 TOPCARE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)] 2 Legacy NDC, 1 package rows 20140520_9e85a8ac-c0b6-4940-9408-9a551fe45a2b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 36800-540-06 36800054006 6 in 1 BOX Historical