NDC 53345-020

Night Cold Flu Cough and Allergy

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

Night Cold Flu Cough and Allergy is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID53345-020_42e74b5b-7b7b-4129-9158-17d06f5b075d
NDC53345-020
Product TypeHuman Otc Drug
Proprietary NameNight Cold Flu Cough and Allergy
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2013-05-29
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-020-01

1 BAG in 1 BOX (53345-020-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2013-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-020-01 [53345002001]

Night Cold Flu Cough and Allergy CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-29

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297288

    • NDC Crossover Matching brand name "Night Cold Flu Cough and Allergy" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    53345-020Night Cold Flu Cough and AllergyNight Cold Flu Cough and Allergy
    0280-1580Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1581Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1600Alka-Seltzer Plus Maximum Strength Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1640Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0280-1610Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1620Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1222Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0113-7501basic care nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0113-7763basic care nigttime cold and flu severeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    41520-770careone allergy and cough severe sinus congestionAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    11822-0591cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    49035-315Day and Night Cold and Flu Formulaacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0363-1658Dye Free Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    46122-272good neighbor pharmacy severe sinus congestionAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    36800-411Night Time Cold and Flu SevereAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    37808-606Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0363-5900nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    21130-595signature care nighttime severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    36800-307topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    36800-594topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    11673-763up and up nighttime severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    11673-251up and up nighttime vapor ice cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
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