NDC 0031-8752

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime is a Oral Solution 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 ID0031-8752_35430576-fbee-4431-9641-4f97e9f09284
NDC0031-8752
Product TypeHuman Otc Drug
Proprietary NameRobitussin Severe Multi-Symptom Cough Cold Flu Nighttime
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/20mL; mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0031-8752-12

1 BOTTLE in 1 CARTON (0031-8752-12) > 118 mL in 1 BOTTLE
Marketing Start Date2015-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8752-18 [00031875218]

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-07-01

NDC 0031-8752-12 [00031875212]

Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-07-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/20mL

OpenFDA Data

SPL SET ID:89360fa8-014d-4da8-bb1c-197e3aa52256
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1375932
  • NDC Crossover Matching brand name "Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0031-8752Robitussin Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, 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
    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
    0067-8124Theraflu Nighttime Multi-Symptom Severe Cold PowderAcetaminophen, 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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