FDA.reportPublic FDA data

Afrin No Drip

Product NDC
11523-3142
11-digit product format
115233142
Labeler code
11523
Product ID
11523-3142_4536fd10-43af-a3a9-e063-6294a90aa6a1
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
1999-08-31
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 No Drip
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
530b2d27-5883-489e-87fa-90b45eb93b3cAvailable 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-3142-1Afrin No DripOriginal Pump Mist15 mL in 1 BOTTLE, PUMPSPRAY, METERED1512
11523-3142-1Afrin No DripOriginal Pump Mist1 in 1 CARTONSPRAY, METERED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-3142-1ML - Milliliter11523-3142b7bc507e-2f66-425b-b1ca-463ac98c779912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7AFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74AFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RAFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-3142AFRIN NO DRIP ORIGINAL PUMP MIST (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 2 package rows20241208_530b2d27-5883-489e-87fa-90b45eb93b3c.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 154 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Nasal Decongestant Maximum Strength Non DrowsyPSEUDOEPHEDRINE HCLTopco Associates LLC1a9e0336-c0c2-43f8-aeea-668d4a2097142024-09-20WarningsExact identifier
application number: M012
Leader Nasal DecongestantPSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader25609b66-047c-46e7-bc95-20eb8e6c96172024-09-20WarningsExact identifier
application number: M012
equaline nasalPHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI67fdd277-7a7a-4404-8ca2-39802c46405f2024-09-20WarningsExact identifier
application number: M012
equaline tussinDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI8bc7fa7c-d565-48c9-9808-1042c3e9d4282024-09-20WarningsExact identifier
application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADERd7fae410-9c1c-4231-9fde-2c51ad3d7e952024-09-20WarningsExact identifier
application number: M012
sinusPSEUDOEPHEDRINE HYDROCHLORIDEKroger Company18812f2a-9b66-45a7-9631-123da6fd1c1f2024-09-20WarningsExact identifier
application number: M012
Good Sense Nasal FourPHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company930469c1-384c-4440-b3e6-9dcd674871c42024-09-19WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC89272d2d-5533-4ae8-865b-cb204cec6d652024-09-17WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC5791c1c7-f614-4940-a45a-6291742e1e222024-09-17WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway2affd44d-2125-4a1f-919c-c082e7644ea82024-09-17WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSYACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINEAdvanced Rx LLCfa1a4d86-87bb-0c50-e053-6394a90a56e22024-09-13WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOMACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAdvanced Rx LLCfa1b60b1-49cb-1211-e053-6394a90a0a462024-09-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEWalgreen Company8db7df1c-46b5-49bd-9002-50b12d58001a2024-09-13WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1bdd7f8a-93ce-5309-e063-6294a90a91f02024-09-12WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltda1103cd8-344b-4a65-8a60-3c7be86d01a62024-09-11WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company276d7d3c-c4a7-4754-8845-c38f85aac5f72024-09-08WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLC4ff5a4ae-9649-4a6d-a5f8-ca23efbbb4792024-09-08WarningsExact identifier
application number: M012
equate nasal originalOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores Inc7e40c9b8-e0b5-448a-a674-72388fbab1892024-09-08WarningsExact identifier
application number: M012
Anefrin Nasal OriginalOXYMETAZOLINE HYDROCHLORIDEWalgreen Company85b442dc-1703-4fef-948a-fad7cbe9f2242024-09-07WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000992Afrin 0.05 % Nasal SprayPSN530b2d27-5883-489e-87fa-90b45eb93b3c12
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN530b2d27-5883-489e-87fa-90b45eb93b3c12
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD530b2d27-5883-489e-87fa-90b45eb93b3c12
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD530b2d27-5883-489e-87fa-90b45eb93b3c12
1000992Afrin 0.05 % Nasal SpraySY530b2d27-5883-489e-87fa-90b45eb93b3c12
1000992Afrin 0.5 MG/ML Nasal SpraySY530b2d27-5883-489e-87fa-90b45eb93b3c12
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY530b2d27-5883-489e-87fa-90b45eb93b3c12
1000992Afrin 0.05 % Nasal SprayPSN16c52c79-baec-87db-e063-6294a90a3b3b2
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN16c52c79-baec-87db-e063-6294a90a3b3b2
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD16c52c79-baec-87db-e063-6294a90a3b3b2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD16c52c79-baec-87db-e063-6294a90a3b3b2
1000992Afrin 0.05 % Nasal SpraySY16c52c79-baec-87db-e063-6294a90a3b3b2
1000992Afrin 0.5 MG/ML Nasal SpraySY16c52c79-baec-87db-e063-6294a90a3b3b2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY16c52c79-baec-87db-e063-6294a90a3b3b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11523-3142-1115233142011 BOTTLE, PUMP in 1 CARTON (11523-3142-1) / 15 mL in 1 BOTTLE, PUMP1999-08-310000-00-00NoNoCurrent