NDC 0713-0535

Formulation R

Phenylephrine Hydrochloride, Hydrogenate Palm Kernel Oil

Formulation R is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by G&w Laboratories, Inc.. The primary component is Phenylephrine Hydrochloride; Hydrogenated Palm Kernel Oil.

Product ID0713-0535_17cecb0a-0c16-cdda-744e-a3dea9333e1e
NDC0713-0535
Product TypeHuman Otc Drug
Proprietary NameFormulation R
Generic NamePhenylephrine Hydrochloride, Hydrogenate Palm Kernel Oil
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2002-06-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameG&W Laboratories, Inc.
Substance NamePHENYLEPHRINE HYDROCHLORIDE; HYDROGENATED PALM KERNEL OIL
Active Ingredient Strength3 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0713-0535-12

12 SUPPOSITORY in 1 CARTON (0713-0535-12)
Marketing Start Date2002-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0713-0535-24 [00713053524]

Formulation R SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2002-06-24
Inactivation Date2020-01-31

NDC 0713-0535-12 [00713053512]

Formulation R SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2002-06-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:a95c678f-84f7-13db-f5b5-05d4d8761fc4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312398

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