NDC 49260-716

Help I Have a Stuffy Nose

Phenylephrine

Help I Have a Stuffy Nose is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Help Remedies, Inc.. The primary component is Phenylephrine Hydrochloride.

Product ID49260-716_c8c22f51-49cf-468f-b5da-177cc774cde5
NDC49260-716
Product TypeHuman Otc Drug
Proprietary NameHelp I Have a Stuffy Nose
Generic NamePhenylephrine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHelp Remedies, Inc.
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49260-716-50

50 TABLET in 1 BOTTLE (49260-716-50)
Marketing Start Date2012-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49260-716-50 [49260071650]

Help I Have a Stuffy Nose TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-01
Inactivation Date2019-11-13

NDC 49260-716-16 [49260071616]

Help I Have a Stuffy Nose TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:2bc595e2-694f-4869-8a86-0be2c1b9b63f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299145
  • NDC Crossover Matching brand name "Help I Have a Stuffy Nose" or generic name "Phenylephrine"

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

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