NDC 57344-120

Acetaminophen, Phenylephrine Hydrochloride

Acetaminophen And Phenylephrine Hydrochloride

Acetaminophen, 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; Phenylephrine Hydrochloride.

Product ID57344-120_7e5d073a-e828-37c5-e053-2a91aa0a4f89
NDC57344-120
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Phenylephrine Hydrochloride
Generic NameAcetaminophen 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; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57344-120-02

2 BLISTER PACK in 1 CARTON (57344-120-02) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2012-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-120-02 [57344012002]

Acetaminophen, 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 57344-120-06 [57344012006]

Acetaminophen, 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 57344-120-03 [57344012003]

Acetaminophen, 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:8e82544d-1350-4421-b990-bfc942ab33c5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046378

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

    NDCBrand NameGeneric Name
    57344-123Acetaminophen, Phenylephrine HydrochlorideAcetaminophen, Phenylephrine Hydrochloride
    57344-154Acetaminophen, Phenylephrine HydrochlorideAcetaminophen, Phenylephrine Hydrochloride
    57344-120Acetaminophen, Phenylephrine HydrochlorideAcetaminophen, Phenylephrine Hydrochloride
    46084-101ACETAMINOPHEN SINUS CONGESTION AND PAINACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    46017-024Contac Cold and Fluacetaminophen and phenylephrine hydrochloride
    46017-021Contac Cold and Flu Dayacetaminophen and phenylephrine hydrochloride
    33992-1100Daytime Sinus ReliefAcetaminophen and Phenylephrine Hydrochloride
    36800-098Daytime Sinus ReliefAcetaminophen and Phenylephrine Hydrochloride
    47682-001Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-002Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    36800-911Pressure and Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-220Pressure and Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-623sinus and headacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    46122-658Sinus and HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    37808-466Sinus Congestion and PainAcetaminophen, Phenylephrine Hydrochloride
    41520-099Sinus DaytimeAcetaminophen and Phenylephrine Hydrochloride
    46122-453Sinus HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    36800-322Sinus plus HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-534Sinus plus HeadacheACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    41250-207sinus pressure and pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    36800-320Sinus Pressure plus Pain PEACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
    37000-507Vicks SinexAcetaminophen and Phenylephrine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.