FDA.reportPublic FDA data

Afrin

Product NDC
11523-1159
11-digit product format
115231159
Labeler code
11523
Product ID
11523-1159_4526eae4-23d0-37f1-e063-6394a90a96cf
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
1975-07-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Afrin
Brand name suffix
Original Pump Mist
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
0f5ec576-f788-40aa-9088-0dd672e3cc7cAvailable 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
11523-1159-1AfrinOriginal Pump Mist1 in 1 CARTONSPRAY, METERED110
11523-1159-1AfrinOriginal Pump Mist15 mL in 1 BOTTLE, PUMPSPRAY, METERED1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-1159-1ML - Milliliter11523-115907b66e3c-4f5f-4ac4-8eab-3fdd1f9813ac12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline hydrochlorideACTIVE INGREDIENTK89MJ0S5VYAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7AFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
povidonesINACTIVE INGREDIENTFZ989GH94EAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74AFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RAFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1159AFRIN ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 2 package rows20241208_0f5ec576-f788-40aa-9088-0dd672e3cc7c.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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000992Afrin 0.05 % Nasal SprayPSN0f5ec576-f788-40aa-9088-0dd672e3cc7c10
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN0f5ec576-f788-40aa-9088-0dd672e3cc7c10
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD0f5ec576-f788-40aa-9088-0dd672e3cc7c10
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD0f5ec576-f788-40aa-9088-0dd672e3cc7c10
1000992Afrin 0.05 % Nasal SpraySY0f5ec576-f788-40aa-9088-0dd672e3cc7c10
1000992Afrin 0.5 MG/ML Nasal SpraySY0f5ec576-f788-40aa-9088-0dd672e3cc7c10
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY0f5ec576-f788-40aa-9088-0dd672e3cc7c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11523-1159-1115231159011 BOTTLE, PUMP in 1 CARTON (11523-1159-1) / 15 mL in 1 BOTTLE, PUMP1975-07-140000-00-00NoNoCurrent