NDC 37012-094

Nasal Decongestant PE

Phenylephrine Hydrochloride

Nasal Decongestant PE is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Shopko Stores Operating Co., Llc. The primary component is Phenylephrine Hydrochloride.

Product ID37012-094_81d64585-0413-415d-8964-c4d5620a3ebe
NDC37012-094
Product TypeHuman Otc Drug
Proprietary NameNasal Decongestant PE
Generic NamePhenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-10-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameShopko Stores Operating Co., LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 37012-094-23

12 BLISTER PACK in 1 CARTON (37012-094-23) > 6 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2013-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37012-094-89 [37012009489]

Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-10-02

NDC 37012-094-23 [37012009423]

Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-10-03

NDC 37012-094-68 [37012009468]

Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-10-03

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:bb5577b6-38b8-4994-b887-be6b82bb5c0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049182