NDC 57344-124

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Aaa Pharmaceutical, Inc.. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID57344-124_7e5d2107-2cf2-2311-e053-2991aa0a9462
NDC57344-124
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-12-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAAA Pharmaceutical, Inc.
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57344-124-02

1 BLISTER PACK in 1 CARTON (57344-124-02) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2012-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-124-03 [57344012403]

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2012-12-23

NDC 57344-124-02 [57344012402]

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-22
Marketing End Date2012-12-23

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:bed954e6-5654-4d41-9f3b-2e8283148294
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1233575

    • NDC Crossover Matching brand name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    57344-155Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    57344-127Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    57344-124Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    57344-156Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    57344-125Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HydrochlorideAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    10202-9647 select night time severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    15127-973Allergy and Cold PEACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    36800-501Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    0031-2249Childrens Dimetapp Multi-Symptom Cold and Fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    30142-964flu 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
    30142-113Kroger NiteTime Flu plus Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    30142-949night time cold and fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    11822-2113Rite Aid Nighttime Severe Cold and Cough ReliefAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    0031-8752Robitussin Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    36800-500Severe Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
    11822-0964severe cold cough and flu reliefAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    15127-974Severe Cold PEAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    36800-504Severe Cold PEAcetaminophen, Diphenhydramine Hydrochloride, and 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
    11673-113up and upAcetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
    0363-0964wal flu severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
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