childrens sudafed nasal decongestant

Generic: pseudoephedrine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens sudafed nasal decongestant
Generic Name pseudoephedrine hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 15 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-536
Product ID 50580-536_21732f4a-40b0-b486-e063-6394a90a1536
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2008-10-01

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580536
Hyphenated Format 50580-536

Supplemental Identifiers

RxCUI
1049143 1049770
UNII
6V9V2RYJ8N

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens sudafed nasal decongestant (source: ndc)
Generic Name pseudoephedrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-536-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-536-04 1 BOTTLE in 1 CARTON (50580-536-04) / 118 mL in 1 BOTTLE

Ingredients (1)

pseudoephedrine hydrochloride (15 mg/5mL)

Linked Drug Pages (1)

Childrens Sudafed Nasal Decongestant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21732f4a-40b0-b486-e063-6394a90a1536", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049143", "1049770"], "spl_set_id": ["52e9307b-ad38-4f65-bb2f-4fa262e82010"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-536-04)  / 118 mL in 1 BOTTLE", "package_ndc": "50580-536-04", "marketing_start_date": "20081001"}], "brand_name": "Childrens Sudafed Nasal Decongestant", "product_id": "50580-536_21732f4a-40b0-b486-e063-6394a90a1536", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "50580-536", "generic_name": "Pseudoephedrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Sudafed", "brand_name_suffix": "Nasal Decongestant", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "15 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20081001", "listing_expiration_date": "20261231"}