FDA.reportPublic FDA data

Afrin

Product NDC
11523-7020
11-digit product format
115237020
Labeler code
11523
Product ID
11523-7020_453715d8-b7e1-c347-e063-6294a90a75c8
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-08-31
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
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
Afrin
Brand name suffix
Severe Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup
1000992Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a49a506e-aca2-4af0-a50b-dca2c031e61dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7020-1AfrinSevere Congestion1 in 1 CARTONSPRAY19
11523-7020-1AfrinSevere Congestion15 mL in 1 BOTTLE, SPRAYSPRAY159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7020-1ML - Milliliter11523-7020fc3de170-d4de-45f4-a4cf-0d8f24558ee012013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline hydrochlorideACTIVE INGREDIENTK89MJ0S5VYAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
camphor (synthetic)INACTIVE INGREDIENT5TJD82A1ETAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
eucalyptolINACTIVE INGREDIENTRV6J6604TKAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
mentholINACTIVE INGREDIENTL7T10EIP3AAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7020AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 2 package rows20241208_a49a506e-aca2-4af0-a50b-dca2c031e61d.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 36 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast DissolveASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.50762d7c-5efd-4f83-e063-6294a90abf7f2026-04-27WarningsExact identifier
application number: M012
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (American Sales Company)bd5de3b3-7cb5-4403-b664-23ac70b9957f2026-04-27WarningsExact identifier
application number: M012
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50364a42-3333-51fe-e063-6394a90ab71e2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
application number: M012
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
application number: M012
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCOSTCO WHOLESALE CORPORATION5180abbc-c6c4-4b82-b6e7-4504e3bcff0f2026-04-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000992Afrin 0.05 % Nasal SprayPSNa49a506e-aca2-4af0-a50b-dca2c031e61d9
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa49a506e-aca2-4af0-a50b-dca2c031e61d9
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBDa49a506e-aca2-4af0-a50b-dca2c031e61d9
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa49a506e-aca2-4af0-a50b-dca2c031e61d9
1000992Afrin 0.05 % Nasal SpraySYa49a506e-aca2-4af0-a50b-dca2c031e61d9
1000992Afrin 0.5 MG/ML Nasal SpraySYa49a506e-aca2-4af0-a50b-dca2c031e61d9
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa49a506e-aca2-4af0-a50b-dca2c031e61d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11523-7020-1115237020011 BOTTLE, SPRAY in 1 CARTON (11523-7020-1) / 15 mL in 1 BOTTLE, SPRAY2000-08-310000-00-00NoNoCurrent