FDA.reportPublic FDA data

NDC 11523-7020-01 - Afrin 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
11523-7020
Requested NDC
11523-7020-01
Package NDCs from labels
11523-7020-1, 11523-7020-01
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 ® Severe CongestionBayer HealthCare LLC.2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7020-1AfrinSevere Congestion1 in 1 CARTONSPRAY19
11523-7020-1AfrinSevere Congestion15 mL in 1 BOTTLE, SPRAYSPRAY159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7020AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 2 package rows20241208_a49a506e-aca2-4af0-a50b-dca2c031e61d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7020-1ML - Milliliter11523-7020fc3de170-d4de-45f4-a4cf-0d8f24558ee012013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline hydrochlorideACTIVE INGREDIENTK89MJ0S5VYAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
camphor (synthetic)INACTIVE INGREDIENT5TJD82A1ETAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
eucalyptolINACTIVE INGREDIENTRV6J6604TKAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
mentholINACTIVE INGREDIENTL7T10EIP3AAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74AFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RAFRIN SEVERE CONGESTION (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]1

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 3 of 344 · 6,867 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: F5UM2KM3W7
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
unii: L7T10EIP3A
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
unii: L7T10EIP3A
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact identifier
application number: M012
Dollar GeneralNASAL PHENYLEPHRINE HYDROCHLORIDEDOLGENCORP, INC. (DOLLAR GENERAL & REXALL)e8fd3f0e-a023-4423-8906-17ae02bc083b2026-09-03WarningsExact identifier
application number: M012
Mucus Relief Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCITARGET Corporation1bf9a59e-cc37-4780-ba75-7138c546eb192026-09-02WarningsExact identifier
application number: M012
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
unii: L7T10EIP3A
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corp.a6880389-0dc1-43a7-a73b-77f77bafe51e2026-09-02WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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