NDC 0498-3331

Sinus Decongestant

Phenylephrine

Sinus Decongestant is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Phenylephrine Hydrochloride.

Product ID0498-3331_762a4a26-b42c-9c12-e053-2a91aa0a3b30
NDC0498-3331
Product TypeHuman Otc Drug
Proprietary NameSinus Decongestant
Generic NamePhenylephrine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-09-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHoneywell Safety Products USA, Inc
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0498-3331-10

100 PACKET in 1 BOTTLE (0498-3331-10) > 2 TABLET in 1 PACKET
Marketing Start Date2018-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0498-3331-50 [00498333150]

Sinus Decongestant TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-18

NDC 0498-3331-10 [00498333110]

Sinus Decongestant TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-18

NDC 0498-3331-25 [00498333125]

Sinus Decongestant TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-18

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:3314b12f-78a0-47d7-91b9-56289179bfe2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299145
  • NDC Crossover Matching brand name "Sinus Decongestant" or generic name "Phenylephrine"

    NDCBrand NameGeneric Name
    0498-3331Sinus DecongestantPhenylephrine
    49260-716Help I Have a Stuffy NosePhenylephrine
    0498-3330North Sinus DecongestantPhenylephrine
    21695-524PhenylephrinePhenylephrine
    42961-333Sine-EEzSinus Decongestant
    42961-205Xpect DecongestantPhenylephrine

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