NDC 0067-8124

Theraflu Nighttime Multi-Symptom Severe Cold Powder

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Theraflu Nighttime Multi-Symptom Severe Cold Powder is a Oral Powder in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID0067-8124_16be0a08-f1de-4da9-a689-c1e71bde4926
NDC0067-8124
Product TypeHuman Otc Drug
Proprietary NameTheraflu Nighttime Multi-Symptom Severe Cold Powder
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage FormPowder
Route of AdministrationORAL
Marketing Start Date2015-07-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0067-8124-06

6 POWDER in 1 CARTON (0067-8124-06)
Marketing Start Date2015-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0067-8124-06 [00067812406]

Theraflu Nighttime Multi-Symptom Severe Cold Powder POWDER
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:ef42d2a3-1bab-4527-8e1e-54e8749cc7b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659175
  • NDC Crossover Matching brand name "Theraflu Nighttime Multi-Symptom Severe Cold Powder" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0067-8124Theraflu Nighttime Multi-Symptom Severe Cold PowderAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    10202-9647 select night time severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    41520-483CareOne Nighttime Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0031-2249Childrens Dimetapp Multi-Symptom Cold and Fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    41163-964equaline flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    30142-964flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    37808-807Flu and Severe Cold and CoughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    41250-964flu 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
    30142-949night time cold and fluacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    0031-8752Robitussin Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
    11822-0964severe cold cough and flu reliefAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    37808-543severe cold, flu and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    21130-020Signature Care severe cold cough and fluAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    36800-964topcare flu and severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
    0363-0964wal flu severe cold and coughAcetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride

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