NDC 10956-813

REESES ONETAB COLD AND FLU

Acetaminophen Diphenhydramine Hydrochloride Phenylephrine Hydrochloride

REESES ONETAB COLD AND FLU is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Reese Pharmaceutical Co.. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID10956-813_36179e63-1f04-41b1-97a5-90c425259f17
NDC10956-813
Product TypeHuman Otc Drug
Proprietary NameREESES ONETAB COLD AND FLU
Generic NameAcetaminophen Diphenhydramine Hydrochloride Phenylephrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-04-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameREESE PHARMACEUTICAL CO.
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 10956-813-01

1 BOTTLE, PLASTIC in 1 CARTON (10956-813-01) > 30 TABLET in 1 BOTTLE, PLASTIC (10956-813-30)
Marketing Start Date2010-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10956-813-30 [10956081330]

REESES ONETAB COLD AND FLU TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-04-05

NDC 10956-813-01 [10956081301]

REESES ONETAB COLD AND FLU TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-04-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

OpenFDA Data

SPL SET ID:628f76d8-0bcf-4eb1-a063-061ccf28ccc9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1147619
  • UPC Code
  • 0023513813301
  • NDC Crossover Matching brand name "REESES ONETAB COLD AND FLU" or generic name "Acetaminophen Diphenhydramine Hydrochloride Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    10956-813REESES ONETAB COLD AND FLUACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE
    10956-812REESES ONETAB ALLERGY AND SINUSACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE

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