NDC 55315-317

Flu Relief Therapy Severe Cough and Cold Nighttime

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Flu Relief Therapy Severe Cough and Cold Nighttime is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Freds Inc. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID55315-317_614ffdec-3e24-42e7-8d4f-65b3371ee6b8
NDC55315-317
Product TypeHuman Otc Drug
Proprietary NameFlu Relief Therapy Severe Cough and Cold Nighttime
Generic NameAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-11-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFreds Inc
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55315-317-08

245 mL in 1 BOTTLE (55315-317-08)
Marketing Start Date2015-11-30
Marketing End Date2024-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-317-08 [55315031708]

Flu Relief Therapy Severe Cough and Cold Nighttime LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-11-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:3fdea931-ee72-47f6-bbbc-be33badd57d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298348
  • UPC Code
  • 0084579107193
  • NDC Crossover Matching brand name "Flu Relief Therapy Severe Cough and Cold Nighttime" or generic name "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    55315-317Flu Relief Therapy Severe Cough and Cold NighttimeFlu Relief Therapy Severe Cough and Cold Nighttime
    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
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.