NDC 36800-964

topcare flu and severe cold and cough

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

topcare flu and severe cold and cough is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID36800-964_502a8657-8fe5-40f6-827e-d7fd8471a222
NDC36800-964
Product TypeHuman Otc Drug
Proprietary Nametopcare flu and severe cold and cough
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2012-09-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/1; mg/1; mg/1
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-964-91

6 POWDER, FOR SOLUTION in 1 CARTON (36800-964-91)
Marketing Start Date2012-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-964-91 [36800096491]

topcare flu and severe cold and cough POWDER, FOR SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-09-10

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:c50c3d9a-0b10-4817-b6bf-505a4046f7cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659960
  • NDC Crossover Matching brand name "topcare flu and severe cold and cough" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    36800-096topcare flu and severe cold and coughAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    36800-964topcare flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    10202-9647 select night time severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0031-2249Childrens Dimetapp Multi-Symptom Cold and Fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    41163-964equaline flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-964flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    37808-807Flu and Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    41250-964flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-317Flu Relief Therapy Severe Cough and ColdAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    0113-0964good sense flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-949night time cold and fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    0031-8752Robitussin Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    11822-0964severe cold cough and flu reliefAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    37808-543severe cold, flu and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    21130-020Signature Care severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0067-8124Theraflu Nighttime Multi-Symptom Severe Cold PowderAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    0363-0964wal flu severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride

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