NDC 57344-138

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, 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; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID57344-138_e63493e7-61f1-4e10-86c3-25e26e18b807
NDC57344-138
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2012-12-28
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAAA Pharmaceutical, Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 57344-138-02

2 BLISTER PACK in 1 CARTON (57344-138-02) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2012-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57344-138-05 [57344013805]

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-28
Marketing End Date2012-12-29

NDC 57344-138-02 [57344013802]

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-28
Marketing End Date2012-12-29

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:431653e0-776b-460a-8db3-c2339393a17d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094538

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

    NDCBrand NameGeneric Name
    57344-138Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HydrochlorideAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    57344-160Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HydrochlorideAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0280-1590Alka-Seltzer Plus Maximum Strength Day Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0280-1630Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
    0280-1221Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels DayAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
    0113-7656basic care daytime cold and fluacetaminophen, dextromethorphan hydrobromide, Phenylephrine hydrochloride
    11868-311Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11868-466Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-468Day timeAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    15127-466Day Time Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0904-5763Day Time Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1140Daytime Cold and Fluacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11822-1583Daytime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1000Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1003Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    21130-311Daytime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-8998Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0113-0096good sense flu and severe cold and coughAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-5556Maximum Strength Congestion and HeadacheAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    0363-9019Maximum Strength Congestion and HeadacheAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    11822-2112Rite Aid Daytime Severe Cold and Cough ReliefAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    0031-8721ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    11822-0096severe cold cough and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    0363-1166Walgreens Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-1167Walgreens Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
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