NDC 50580-536

Childrens Sudafed Nasal Decongestant

Pseudoephedrine Hydrochloride

Childrens Sudafed Nasal Decongestant is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Pseudoephedrine Hydrochloride.

Product ID50580-536_5ebcf366-e81f-4ed7-8efd-2b03411f74ad
NDC50580-536
Product TypeHuman Otc Drug
Proprietary NameChildrens Sudafed Nasal Decongestant
Generic NamePseudoephedrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2008-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-536-04

1 BOTTLE in 1 CARTON (50580-536-04) > 118 mL in 1 BOTTLE
Marketing Start Date2008-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-536-04 [50580053604]

Childrens Sudafed Nasal Decongestant SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2008-10-01

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE15 mg/5mL

OpenFDA Data

SPL SET ID:52e9307b-ad38-4f65-bb2f-4fa262e82010
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049143
  • 1049770
  • NDC Crossover Matching brand name "Childrens Sudafed Nasal Decongestant" or generic name "Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-536Childrens Sudafed Nasal DecongestantChildrens Sudafed Nasal Decongestant
    0113-205412 hour decongestantPseudoephedrine Hydrochloride
    30142-05412 hour decongestantPseudoephedrine Hydrochloride
    41250-05412 hour decongestantPseudoephedrine Hydrochloride
    41163-054Equaline 12 Hour DecongestantPseudoephedrine Hydrochloride
    24385-054good neighbor pharmacy nasal decongestantPseudoephedrine Hydrochloride
    0113-0054Good Sense SuphedrinePseudoephedrine Hydrochloride
    37205-446Leader 12 Hour Nasal DecongestantPseudoephedrine Hydrochloride
    0363-3301Nasal Decongestant DPseudoephedrine Hydrochloride
    0363-0204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6727Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6728Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6907Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    21130-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    30142-967Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDE
    37012-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37808-007Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37808-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0536-1850RugbyPseudoephedrine Hydrochloride
    30142-613sinusPseudoephedrine hydrochloride
    0904-5125SudoGestPseudoephedrine Hydrochloride
    0904-5803SudoGestPseudoephedrine Hydrochloride
    21695-806SudoGestPseudoephedrine Hydrochloride
    21695-898SudoGestPseudoephedrine Hydrochloride
    33261-651SudoGestPseudoephedrine Hydrochloride
    36800-054topcare 12 hour decongestantPseudoephedrine Hydrochloride
    0113-0401Zephrex Dpseudoephedrine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.