FDA.reportPublic FDA data

Topcare Cold and Sore Throat

Product NDC
36800-802
11-digit product format
368000802
Labeler code
36800
Product ID
36800-802_1a65c0d8-e9dd-4c1c-801b-b5a505a4ccc2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Pheniramine Maleate, Phenylephrine HCl
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
TOPCARE (Topco Associates LLC)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-05-20
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-802-062020-01-31C16284748780-19d75b9d0-a8c1-f424-e053-dadaa90a57ceTopcare Cold and Sore Throat Lemon Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-802-06Topcare Cold and Sore ThroatLemon Flavor6 in 1 BOXGRANULE, FOR SOLUTION61

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Pheniramine MaleateACTIVE INGREDIENTNYW905655BTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
AcetaminophenACTIVE MOIETY362O9ITL9DTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
PheniramineACTIVE MOIETY134FM9ZZ6MTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
PhenylephrineACTIVE MOIETY1WS297W6MVTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Ethylcellulose (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
PovidoneINACTIVE INGREDIENTFZ989GH94ETOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
Sodium citrateINACTIVE INGREDIENT1Q73Q2JULRTOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1
SucroseINACTIVE INGREDIENTC151H8M554TOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-802TOPCARE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [TOPCARE (TOPCO ASSOCIATES LLC)]1Legacy NDC, 1 package rows20140521_ef12626d-dc9e-4e07-9e97-6edf0ea82f9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionPSNef12626d-dc9e-4e07-9e97-6edf0ea82f9c1
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSCDef12626d-dc9e-4e07-9e97-6edf0ea82f9c1
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Granule for Oral SolutionSYef12626d-dc9e-4e07-9e97-6edf0ea82f9c1
1796460acetaminophen 325 MG / pheniramine maleate 20 MG / phenylephrine hydrochloride 10 MG Packet for Oral SolutionSYef12626d-dc9e-4e07-9e97-6edf0ea82f9c1
1796460APAP 325 MG / Pheniramine Maleate 20 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral SolutionSYef12626d-dc9e-4e07-9e97-6edf0ea82f9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-802-06368000802066 in 1 BOXHistorical