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 47 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012
NIGHTTIME CHERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.36924420-f514-4225-e063-6294a90a330c2026-03-03WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP4584d701-5a4e-e54e-e063-6394a90a38d62026-03-03WarningsExact identifier
application number: M012
foster and thrive nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESportpharm LLC7bdfd2ef-bb99-41f5-97ae-3a02c994bddd2026-03-03WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLCd27b5976-8cc0-4d99-96f6-9069b786affd2026-03-03WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINA-S Medication Solutions7f703c9c-2256-4524-9d31-c51919399d262026-03-03WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)f49f1e9a-07ac-443e-9df8-3281d5f35e782026-03-03WarningsExact identifier
application number: M012
berkley and jensen nasalOXYMETAZOLINE HYDROCHLORIDEBJWC77cbe75d-4ed9-4a8b-91dc-1cc28af255082026-03-02WarningsExact identifier
application number: M012
childrens cold and cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWalgreen Company6c7c950d-ed48-4428-9e9e-73684cabc6992026-02-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.1f737b76-14b5-618a-e063-6294a90a19c22026-02-27WarningsExact identifier
application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEFDOXYLAMINE SUCCINATEWALGREENS CO.a3c7df98-4611-4b61-9c03-5e687364bf742026-02-27WarningsExact identifier
application number: M012
MEIJER Childrens Allergy Relief ChewsDIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC3368e081-a3b2-4c03-8bd1-05cc6af0391d2026-02-27WarningsExact identifier
application number: M012
CVS PHARMACY Nighttime MS Flu ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY23cafaa1-34fe-4cef-960b-5f664ea32cb42026-02-27WarningsExact identifier
application number: M012
Tussin DM Cough and ChestDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC402969c9-945c-44b7-b018-b62f427ce5712026-02-26WarningsExact identifier
application number: M012
nasal originalOXYMETAZOLINE HYDROCHLORIDEHyVee Incd997f264-1b4a-4cca-a282-bd9645d55bfd2026-02-26WarningsExact identifier
application number: M012
Multi-Symptom Cold and Fever ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY2a569e47-3f17-4fc7-83d6-a3dddfd4987e2026-02-25WarningsExact identifier
application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED184059b7-9238-480e-be4a-ed105f13c19d2026-02-25WarningsExact 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