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

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
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 80 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEChain Drug Manufacturing Assnce658dd5-b683-436e-b16b-0c06f6f87fd92025-12-04WarningsExact identifier
application number: M012
Quality Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa87ba15f-b5a9-4983-a721-ca7f705aea862025-12-04WarningsExact identifier
application number: M012
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsExact identifier
application number: M012
Childrens Mucus Relief Chest CongestionGUAIFENESINChain Drug Manufacturing Assn034d39c0-9aad-4dff-a158-a041b9f0504f2025-12-04WarningsExact identifier
application number: M012
Quality ChoiceOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd01b8fb6-1ddf-4901-bda6-ae608e94a6a42025-12-04WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEChain Drug Manufacturing Assn06822a28-3f82-471d-8db5-c5981b263a032025-12-04WarningsExact identifier
application number: M012
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsExact identifier
application number: M012
Daytime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Incfd5c20ed-5520-4db0-bfd4-995f043af2a42025-12-04WarningsExact identifier
application number: M012
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a2b30c27-b836-f09f-e053-2995a90ac3832025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast FizzASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.a37c9d9d-52db-23ff-e053-2995a90a8f762025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a68df74d-dd26-3ae9-e053-2995a90a08d62025-12-04WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.55662ada-677e-4048-9529-5bca440763162025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.b13d5132-cb91-3cf6-e053-2a95a90aa47c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast FizzCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.bd97e91f-1ae1-379c-e053-2995a90acfdd2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a6a2dd4a-a3c8-2dfa-e053-2995a90ada862025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling Original PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.bd49121c-7cba-c51f-e053-2995a90a921e2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.a6b8dc25-0fb9-1823-e053-2a95a90adf932025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c2232241-6e57-1427-e053-2995a90a488a2025-12-04WarningsExact 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