NDC 55315-047

Cold Head Congestion Daytime

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl

Cold Head Congestion Daytime is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID55315-047_f5ea5552-39ae-4f54-8313-1a5fffd9ea49
NDC55315-047
Product TypeHuman Otc Drug
Proprietary NameCold Head Congestion Daytime
Generic NameAcetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-07-15
Marketing End Date2022-08-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFRED'S, INC.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN

Packaging

NDC 55315-047-08

2 BLISTER PACK in 1 BOX (55315-047-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2005-07-15
Marketing End Date2022-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-047-08 [55315004708]

Cold Head Congestion Daytime TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-07-15
Marketing End Date2022-08-22

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:df1d0ebb-8329-4282-b4ea-f4d03c39916f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094538
    • UPC Code
  • 0084579105120

    • NDC Crossover Matching brand name "Cold Head Congestion Daytime" or generic name "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    41520-603Cold Head Congestion DaytimeCold Head Congestion Daytime
    55315-047Cold Head Congestion DaytimeCold Head Congestion Daytime
    0113-7994basic care daytime cold and fluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0113-7690basic care severe cold and fluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-0560ColdAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-0666Cold and Fluacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0363-6590Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-7301Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0067-2077COMTREXAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-0656Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0113-0064Good Sense Cold MaxAcetaminophen, Dextromethorphan hbr, Phenylephrine hcl
    0113-0656Good Sense Daytimeacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0113-0994good sense daytimeAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0113-0023good sense multi symptom flu and severe coldAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-5470Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0067-6426THERAFLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0067-8127Theraflu ExpressMaxAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0067-8136Theraflu ExpressMaxacetaminophen, dextromethorphan HBr, phenylephrine HCl
    0363-8319wal flu severe coldAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    0363-5110Wal-PhedAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
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