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#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-800-062020-01-31C16284748780-19d75b9d1-0000-f424-e053-dadaa90a57ceTopcare Nighttime Severe Cold and Cough Honey lemon infused with Chamomile and White tea flavors

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-800-06TopCare Nighttime Severe Cold and Coughhoney lemon infused with chamomile and white tea flavors6 in 1 BOXGRANULE, FOR SOLUTION62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTOPCARE 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 HydrochlorideACTIVE INGREDIENTTC2D6JAD40TOPCARE 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 HydrochlorideACTIVE INGREDIENT04JA59TNSJTOPCARE 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
AcetaminophenACTIVE MOIETY362O9ITL9DTOPCARE 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
DiphenhydramineACTIVE MOIETY8GTS82S83MTOPCARE 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
PhenylephrineACTIVE MOIETY1WS297W6MVTOPCARE 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
AcesulfameINACTIVE INGREDIENTMA3UYZ6K1HTOPCARE 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
AspartameINACTIVE INGREDIENTZ0H242BBR1TOPCARE 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 monohydrateINACTIVE INGREDIENT2968PHW8QPTOPCARE 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
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DTOPCARE 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 CitrateINACTIVE INGREDIENT1Q73Q2JULRTOPCARE 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
SucroseINACTIVE INGREDIENTC151H8M554TOPCARE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-800TOPCARE 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)]2Legacy NDC, 1 package rows20140520_31108eec-b555-4dd3-afe3-4073cb1be075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN31108eec-b555-4dd3-afe3-4073cb1be0752
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD31108eec-b555-4dd3-afe3-4073cb1be0752
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY31108eec-b555-4dd3-afe3-4073cb1be0752
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY31108eec-b555-4dd3-afe3-4073cb1be0752
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY31108eec-b555-4dd3-afe3-4073cb1be0752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-800-06368000800066 in 1 BOXHistorical