NDC 21695-524

Phenylephrine

Phenylephrine

Phenylephrine is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Phenylephrine Hydrochloride.

Product ID21695-524_c40df8f6-8374-4f9b-bfce-94d582470d48
NDC21695-524
Product TypeHuman Otc Drug
Proprietary NamePhenylephrine
Generic NamePhenylephrine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRebel Distributors Corp
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-524-18

18 TABLET in 1 BLISTER PACK (21695-524-18)
Marketing Start Date2010-02-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-524-18 [21695052418]

Phenylephrine TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2010-02-24
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:c40df8f6-8374-4f9b-bfce-94d582470d48
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049182
  • NDC Crossover Matching brand name "Phenylephrine" or generic name "Phenylephrine"

    NDCBrand NameGeneric Name
    21695-524PhenylephrinePhenylephrine
    49260-716Help I Have a Stuffy NosePhenylephrine
    0498-3330North Sinus DecongestantPhenylephrine
    0498-3331Sinus DecongestantPhenylephrine
    42961-205Xpect DecongestantPhenylephrine

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