Home NDC 80070-400 Dristan
Product NDC 80070-400
11-digit product format 800700400
Labeler code 80070
Product ID 80070-400_41e7cd3f-510d-0976-e063-6394a90abe9e
Type HUMAN OTC DRUG
Nonproprietary name OXYMETAZOLINE HYDROCHLORIDE
Dosage form SPRAY
Route NASAL
Labeler Foundation Consumer Brands
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-17
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .5 mg/mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dristan
Brand name suffix 12 hr
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K89MJ0S5VY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000990 Internal RxNorm lookup 1000996 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80070-400-05 Dristan12 hr 15 mL in 1 BOTTLE, SPRAY SPRAY 15 3 80070-400-05 Dristan12 hr 1 in 1 CARTON SPRAY 1 3 80070-400-15 Dristan12 hr 45 mL in 1 CARTON SPRAY 45 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80070-400 DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [FOUNDATION CONSUMER BRANDS] 2 Current NDC, Legacy NDC, 3 package rows 20241109_522876fe-a412-4ca8-bfad-a313e3cbc1af.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 98 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80070-400-05 80070040005 1 BOTTLE, SPRAY in 1 CARTON (80070-400-05) / 15 mL in 1 BOTTLE, SPRAY 2021-08-17 0000-00-00 No No Current 80070-400-15 80070040015 45 mL in 1 CARTON (80070-400-15) 45 ml 2025-11-01 No No Current