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 9 of 351 · 7,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
unii: F5UM2KM3W7
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
BOTASUN SMELLING SALTSMENTHO 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.59a02fae-b413-bd93-e063-6394a90a80642026-08-22WarningsExact identifier
unii: L7T10EIP3A
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
unii: L7T10EIP3A
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
ZYLOTROL MAXIMUM PAINLIDOCAINE 4%, MENTHOL 1%Whitestone Products LLCa80efad7-1d8b-4d8b-8c97-373174ce89ca2026-08-21WarningsExact identifier
unii: L7T10EIP3A
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
unii: F5UM2KM3W7
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
unii: F5UM2KM3W7
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLYour Military Exchangesd0ede39c-4b05-47c7-9c0b-9e893dcdb7232026-08-21Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
Tartar control plus AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLNice-Pak Products, LLC37be182d-16be-4edb-bccb-87c7cb5c39c22026-08-21Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: RV6J6604TK
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
PARCHE FRIOMETHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCHDW SUPPORT LLC5970a6f7-b273-9bb1-e063-6394a90afc792026-08-21WarningsExact identifier
unii: L7T10EIP3A
unii: 5TJD82A1ET
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Softsoap Antibacterial Clean and Protect Cool SplashBENZALKONIUM CHLORIDECOLGATE PALMOLIVE COMPANY7d48e018-0874-4bbf-a95e-dc21702406c12026-08-20WarningsExact identifier
unii: F5UM2KM3W7
SC HERBALMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCf34ad1c1-9b4d-4efa-b824-7b7ff53509742026-08-20WarningsExact identifier
unii: L7T10EIP3A
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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