oxymetazoline hydrochloride

Generic: oxymetazoline hydrochloride

Labeler: prodose, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name oxymetazoline hydrochloride
Generic Name oxymetazoline hydrochloride
Labeler prodose, inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

oxymetazoline hydrochloride .05 g/100mL

Manufacturer
Prodose, Inc.

Identifiers & Regulatory

Product NDC 68210-5056
Product ID 68210-5056_4a874cfa-f2fd-bbef-e063-6294a90af801
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-09-03

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 682105056
Hyphenated Format 68210-5056

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 oxymetazoline hydrochloride (source: ndc)
Generic Name oxymetazoline hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • .05 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (68210-5056-1) / 15 mL in 1 BOTTLE, PUMP
source: ndc

Packages (1)

68210-5056-1 1 BOTTLE, PUMP in 1 CARTON (68210-5056-1) / 15 mL in 1 BOTTLE, PUMP

Ingredients (1)

oxymetazoline hydrochloride (.05 g/100mL)

Linked Drug Pages (1)

Oxymetazoline hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "4a874cfa-f2fd-bbef-e063-6294a90af801", "openfda": {"unii": ["K89MJ0S5VY"], "rxcui": ["1000990"], "spl_set_id": ["3dce34f0-9f6d-8151-e063-6394a90a1d38"], "manufacturer_name": ["Prodose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68210-5056-1)  / 15 mL in 1 BOTTLE, PUMP", "package_ndc": "68210-5056-1", "marketing_start_date": "20250903"}], "brand_name": "Oxymetazoline hydrochloride", "product_id": "68210-5056_4a874cfa-f2fd-bbef-e063-6294a90af801", "dosage_form": "SPRAY", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "68210-5056", "generic_name": "Oxymetazoline hydrochloride", "labeler_name": "Prodose, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Oxymetazoline hydrochloride", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": ".05 g/100mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250903", "listing_expiration_date": "20271231"}