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 2 of 344 · 6,867 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
unii: F5UM2KM3W7
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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