NDC 50580-784

Childrens Sudafed PE NASAL DECONGESTANT

Phenylephrine Hydrochloride

Childrens Sudafed PE 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 Phenylephrine Hydrochloride.

Product ID50580-784_49041770-7e7d-4470-8f64-acd9ade50d04
NDC50580-784
Product TypeHuman Otc Drug
Proprietary NameChildrens Sudafed PE NASAL DECONGESTANT
Generic NamePhenylephrine 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 NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength3 mg/5mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50580-784-04

1 BOTTLE in 1 CARTON (50580-784-04) > 118 mL in 1 BOTTLE
Marketing Start Date2008-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-784-04 [50580078404]

Childrens Sudafed PE 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
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

OpenFDA Data

SPL SET ID:4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827706
  • 692479

    • NDC Crossover Matching brand name "Childrens Sudafed PE NASAL DECONGESTANT" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-784Childrens Sudafed PE NASAL DECONGESTANTChildrens Sudafed PE NASAL DECONGESTANT
    0067-20864 WayPhenylephrine hydrochloride
    0113-7094basic care sinus pePhenylephrine Hydrochloride
    0363-0390ephrine nosePhenylephrine hydrochloride
    0363-2023Ephrine Nose DropsPhenylephrine hydrochloride
    0113-0094Good Sense Nasal Decongestant PEPhenylephrine Hydrochloride
    0113-0648Good Sense Nasal FourPhenylephrine hydrochloride
    0295-1217Little Remedies Decongestant Nose DropsPhenylephrine Hydrochloride
    0363-0717nasalPhenylephrine hydrochloride
    0295-1117Neo-SynephrinePhenylephrine hydrochloride
    0295-1118Neo-SynephrinePhenylephrine hydrochloride
    0295-1119Neo-SynephrinePhenylephrine hydrochloride
    0225-0800Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDE
    0225-0805Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0225-0810Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0363-0394phenylephrine hydrochloridephenylephrine hydrochloride
    0404-9931Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6142Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6188Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6189Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6229Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3422Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3458Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0113-2004sinus PEPhenylephrine Hydrochloride
    0363-0648Wal FourPhenylephrine hydrochloride
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