dristan 12 hr

Generic: oxymetazoline hydrochloride

Labeler: foundation consumer brands
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dristan 12 hr
Generic Name oxymetazoline hydrochloride
Labeler foundation consumer brands
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

oxymetazoline hydrochloride .5 mg/mL

Manufacturer
Foundation Consumer Brands

Identifiers & Regulatory

Product NDC 80070-400
Product ID 80070-400_41e7cd3f-510d-0976-e063-6394a90abe9e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-08-17

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 80070400
Hyphenated Format 80070-400

Supplemental Identifiers

RxCUI
1000990 1000996
UPC
0850024431003
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 dristan 12 hr (source: ndc)
Generic Name oxymetazoline hydrochloride (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 (80070-400-05) / 15 mL in 1 BOTTLE, SPRAY
  • 45 mL in 1 CARTON (80070-400-15)
source: ndc

Packages (2)

80070-400-05 1 BOTTLE, SPRAY in 1 CARTON (80070-400-05) / 15 mL in 1 BOTTLE, SPRAY 80070-400-15 45 mL in 1 CARTON (80070-400-15)

Ingredients (1)

oxymetazoline hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

Dristan 12 hr ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "41e7cd3f-510d-0976-e063-6394a90abe9e", "openfda": {"upc": ["0850024431003"], "unii": ["K89MJ0S5VY"], "rxcui": ["1000990", "1000996"], "spl_set_id": ["522876fe-a412-4ca8-bfad-a313e3cbc1af"], "manufacturer_name": ["Foundation Consumer Brands"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (80070-400-05)  / 15 mL in 1 BOTTLE, SPRAY", "package_ndc": "80070-400-05", "marketing_start_date": "20210817"}, {"sample": false, "description": "45 mL in 1 CARTON (80070-400-15)", "package_ndc": "80070-400-15", "marketing_start_date": "20251101"}], "brand_name": "Dristan 12 hr", "product_id": "80070-400_41e7cd3f-510d-0976-e063-6394a90abe9e", "dosage_form": "SPRAY", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "80070-400", "generic_name": "OXYMETAZOLINE HYDROCHLORIDE", "labeler_name": "Foundation Consumer Brands", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dristan", "brand_name_suffix": "12 hr", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210817", "listing_expiration_date": "20261231"}