theraflu severe congestion relief cooling nasal mist

Generic: oxymetazoline hcl

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name theraflu severe congestion relief cooling nasal mist
Generic Name oxymetazoline hcl
Labeler haleon us holdings llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

oxymetazoline hydrochloride .5 mg/mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0109
Product ID 0067-0109_6aa3b201-92f0-4735-b4fc-e464836b3aac
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

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 00670109
Hyphenated Format 0067-0109

Supplemental Identifiers

RxCUI
1000990
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 theraflu severe congestion relief cooling nasal mist (source: ndc)
Generic Name oxymetazoline hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (0067-0109-01) / 10 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0067-0109-01 1 BOTTLE, SPRAY in 1 CARTON (0067-0109-01) / 10 mL in 1 BOTTLE, SPRAY

Ingredients (1)

oxymetazoline hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Theraflu Severe Congestion Relief Cooling Nasal Mist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "6aa3b201-92f0-4735-b4fc-e464836b3aac", "openfda": {"unii": ["K89MJ0S5VY"], "rxcui": ["1000990"], "spl_set_id": ["90125a19-eed7-4ca4-a6dc-f38026c74d54"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (0067-0109-01)  / 10 mL in 1 BOTTLE, SPRAY", "package_ndc": "0067-0109-01", "marketing_start_date": "20250601"}], "brand_name": "Theraflu Severe Congestion Relief Cooling Nasal Mist", "product_id": "0067-0109_6aa3b201-92f0-4735-b4fc-e464836b3aac", "dosage_form": "SPRAY", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "0067-0109", "generic_name": "Oxymetazoline HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Theraflu", "brand_name_suffix": "Severe Congestion Relief Cooling Nasal Mist", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}