Home NDC 36800-800
TopCare Nighttime Severe Cold and Cough
Product NDC 36800-800
11-digit product format 368000800
Labeler code 36800
Product ID 36800-800_9d086914-86f6-45f3-8bfa-4bdb00fdc3bf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-03-18
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; 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 36800-800-06 TopCare Nighttime Severe Cold and Coughhoney lemon infused with chamomile and white 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 NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Diphenhydramine Hydrochloride ACTIVE INGREDIENT TC2D6JAD40 TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Acetaminophen ACTIVE MOIETY 362O9ITL9D TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Diphenhydramine ACTIVE MOIETY 8GTS82S83M TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Acesulfame INACTIVE INGREDIENT MA3UYZ6K1H TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Aspartame INACTIVE INGREDIENT Z0H242BBR1 TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Maltodextrin INACTIVE INGREDIENT 7CVR7L4A2D TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Sucrose INACTIVE INGREDIENT C151H8M554 TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-800 TOPCARE NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOP CARE (TOPCO ASSOCIATES LLC)] 2 Legacy NDC, 1 package rows 20140520_31108eec-b555-4dd3-afe3-4073cb1be075.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 36800-800-06 36800080006 6 in 1 BOX Historical