sudafed om sinus severe original

Generic: oxymetazoline hydrochloride

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

Drug Facts

Product Profile

Brand Name sudafed om sinus severe original
Generic Name oxymetazoline hydrochloride
Labeler kenvue brands llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

oxymetazoline hydrochloride 50 mg/100mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-787
Product ID 50580-787_291005be-b77a-be4a-e063-6294a90a04f0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-09-04

Pharmacologic Class

Classes
imidazolines [cs] increased sympathetic activity [pe] vasoconstriction [pe] vasoconstrictor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580787
Hyphenated Format 50580-787

Supplemental Identifiers

RxCUI
1000990 1001081
UPC
0300450528018
UNII
K89MJ0S5VY

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 sudafed om sinus severe original (source: ndc)
Generic Name oxymetazoline hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-787-01) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-787-01 1 BOTTLE in 1 CARTON (50580-787-01) / 30 mL in 1 BOTTLE

Ingredients (1)

oxymetazoline hydrochloride (50 mg/100mL)

Linked Drug Pages (1)

SUDAFED OM Sinus Severe Original ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "291005be-b77a-be4a-e063-6294a90a04f0", "openfda": {"upc": ["0300450528018"], "unii": ["K89MJ0S5VY"], "rxcui": ["1000990", "1001081"], "spl_set_id": ["1d089074-3969-ce6e-e063-6294a90aa70c"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-787-01)  / 30 mL in 1 BOTTLE", "package_ndc": "50580-787-01", "marketing_start_date": "20240904"}], "brand_name": "SUDAFED OM Sinus Severe Original", "product_id": "50580-787_291005be-b77a-be4a-e063-6294a90a04f0", "dosage_form": "SPRAY", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "50580-787", "generic_name": "Oxymetazoline Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SUDAFED OM Sinus Severe Original", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": "50 mg/100mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240904", "listing_expiration_date": "20261231"}