Home NDC 11523-0091 Children Afrin Extra Moisturizing Stuffy Nose Pump Mist
Product NDC 11523-0091
11-digit product format 115230091
Labeler code 11523
Product ID 11523-0091_4526d3b2-bf61-2bf3-e063-6394a90a4fad
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline hydrochloride
Dosage form SPRAY, METERED
Route NASAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-03
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .025 g/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Children Afrin Extra Moisturizing Stuffy Nose Pump Mist
Brand name suffix Stuffy Nose Pump Mist
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .025 g/100mL
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 2606550 Internal RxNorm lookup 2606551 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 11523-0091-1 Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist 15 mL in 1 BOTTLE, PUMP SPRAY, METERED 15 9 11523-0091-1 Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist 1 in 1 CARTON SPRAY, METERED 1 9 11523-0091-2 Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist 2 in 1 CARTON SPRAY, METERED 2 9 11523-0091-2 Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist 15 mL in 1 BOTTLE, PUMP SPRAY, METERED 15 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0091 CHILDREN AFRIN EXTRA MOISTURIZING STUFFY NOSE PUMP MIST STUFFY NOSE PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.] 8 Current NDC, Legacy NDC, 4 package rows 20241208_e3b239bd-ffc7-600c-e053-2a95a90a3b3b.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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 11523-0091-1 11523009101 1 BOTTLE, PUMP in 1 CARTON (11523-0091-1) / 15 mL in 1 BOTTLE, PUMP 2022-07-14 0000-00-00 No No Current 11523-0091-2 11523009102 2 BOTTLE, PUMP in 1 CARTON (11523-0091-2) / 15 mL in 1 BOTTLE, PUMP 2022-12-02 0000-00-00 No No Current