NDC 59779-526

Severe Cold Relief PE

Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl

Severe Cold Relief PE is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Woonsocket Prescription Center, Incorporated. The primary component is Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID59779-526_ac825d18-735f-6052-46fa-14a834979c8c
NDC59779-526
Product TypeHuman Otc Drug
Proprietary NameSevere Cold Relief PE
Generic NameAcetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-06-21
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameWOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59779-526-08

1 BLISTER PACK in 1 CARTON (59779-526-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2005-06-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59779-526-02 [59779052602]

Severe Cold Relief PE TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-06-21
Inactivation Date2020-01-31

NDC 59779-526-08 [59779052608]

Severe Cold Relief PE TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-06-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:5a251962-305d-101b-e7fa-cb6b50c20a4f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1233575
  • UPC Code
  • 0050428088456
  • NDC Crossover Matching brand name "Severe Cold Relief PE" or generic name "Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    59779-526Severe Cold Relief PESevere Cold Relief PE
    13411-839AcetaFlu NightTimeAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    13411-841AcetaFlu NightTime EffervescentAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    41250-464Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    0363-5430Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
    15127-862Flu and Sore ThroatAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    36800-317Flu Relief TherapyAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    46122-016Flu Relief TherapyAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    15127-922Flu Relief Therapy NighttimeAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    46122-268good neighbor pharmacy cold and flu night timeAcetaminophen, diphenhydramine HCl, phenylephrine HCl
    46122-311Nighttime Flu Relief TherapyAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    11822-0543Severe Allergy And Sinus HeadacheAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    41250-543Severe Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    49035-543Severe Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    37808-017Severe Cold and Cough ReliefAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    42507-317Severe Cold and Cough ReliefAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    0067-6095THERAFLUACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
    0067-7918THERAFLUACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
    0067-8129Theraflu ExpressMaxAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    0067-8131Theraflu ExpressMaxAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl
    0067-8137Theraflu ExpressMaxacetaminophen, diphenhydramine HCl, phenylephrine HCl
    36800-999topcare cold and flu night timeAcetaminophen, diphenhydramine HCl, phenylephrine HCl
    36800-919Topcare TussinAcetaminophen, diphenhydramine HCl, phenylephrine HCl
    36800-902topcare tussin cf maxAcetaminophen, diphenhydramine HCl, phenylephrine HCl
    0363-0543Wal-DrylAcetaminophen, Diphenhydramine HCl, Phenylephrine HCl

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