FDA.reportPublic FDA data

NDC 11523-1350-01 - Afrin No Drip Severe Congestion

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
11523-1350
Requested NDC
11523-1350-01
Package NDCs from labels
11523-1350-1, 11523-1350-2, 11523-1350-4, 11523-1350-3, 11523-1350-01
Manufacturer
Bayer HealthCare LLC
Effective date
2025-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Afrin No Drip Severe Congestion - Bayer HealthCare LLCBayer HealthCare LLC2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1350-1Afrin No DripSevere Congestion15 mL in 1 BOTTLE, PUMPSPRAY, METERED1514
11523-1350-1Afrin No DripSevere Congestion1 in 1 CARTONSPRAY, METERED114
11523-1350-2Afrin No DripSevere Congestion20 mL in 1 BOTTLE, PUMPSPRAY, METERED2014
11523-1350-2Afrin No DripSevere Congestion2 in 1 CARTONSPRAY, METERED214
11523-1350-3Afrin No DripSevere Congestion2 in 1 CARTONSPRAY, METERED214
11523-1350-3Afrin No DripSevere Congestion15 mL in 1 BOTTLE, PUMPSPRAY, METERED1514
11523-1350-4Afrin No DripSevere Congestion20 mL in 1 BOTTLE, PUMPSPRAY, METERED2014
11523-1350-4Afrin No DripSevere Congestion3 in 1 CARTONSPRAY, METERED314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1350AFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]13Current NDC, Legacy NDC, 8 package rows20241010_a79b5541-864b-412a-a085-96986ed6af59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-1350-1ML - Milliliter11523-13506b57f8c6-8474-46e7-a203-4acb534f09ef12013-09-04
11523-1350-2ML - Milliliter11523-135095f2b6bb-3eda-4879-90c4-8a54d59a796512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7AFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74AFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RAFRIN NO DRIP SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC]2

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 8 of 351 · 7,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
unii: L7T10EIP3A
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
unii: L7T10EIP3A
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Kreain Nature Soothing CoolingKREAIN NATURE SOOTHING COOLINGWANWANG INC59e046de-2be7-26bd-e063-6394a90a4b312026-08-25WarningsExact identifier
unii: L7T10EIP3A
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
unii: F5UM2KM3W7
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
unii: L7T10EIP3A
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
unii: L7T10EIP3A
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.