FDA.reportPublic FDA data

Afrin

Product NDC
11523-1167
11-digit product format
115231167
Labeler code
11523
Product ID
11523-1167_452362c1-c953-c5d7-e063-6294a90ad7c4
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1975-07-14
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11523-116711523-1167-4DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-116711523-1167-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Brand name suffix
Original
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
89c165ba-3ad5-49b5-a5bb-423dc8e15badAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1167-1AfrinOriginal6 mL in 1 BOTTLE, SPRAYSPRAY612
11523-1167-2AfrinOriginal21 mL in 1 BOTTLE, SPRAYSPRAY2112
11523-1167-2AfrinOriginal2 in 1 CARTONSPRAY212
11523-1167-3AfrinOriginal1 in 1 CARTONSPRAY112
11523-1167-3AfrinOriginal20 mL in 1 BOTTLE, SPRAYSPRAY2012
11523-1167-4AfrinOriginal3 in 1 CARTONSPRAY312
11523-1167-4AfrinOriginal30 mL in 1 BOTTLE, SPRAYSPRAY3012
11523-1167-5AfrinOriginal30 mL in 1 BOTTLE, SPRAYSPRAY3012
11523-1167-5AfrinOriginal1 in 1 CARTONSPRAY112
11523-1167-6AfrinOriginal15 mL in 1 BOTTLE, SPRAYSPRAY1512
11523-1167-6AfrinOriginal1 in 1 CARTONSPRAY112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-1167-3ML - Milliliter11523-1167e6b61680-eaad-4ff1-a0d4-d25116e1ada112015-10-02
11523-1167-5ML - Milliliter11523-1167892df7b8-5889-48d3-9cdf-70a8f33e8c4912013-10-17
11523-1167-6ML - Milliliter11523-11675797e12f-28cc-49e5-bfd1-5dc75045522c12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline hydrochlorideACTIVE INGREDIENTK89MJ0S5VYAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
OxymetazolineACTIVE MOIETY8VLN5B44ZYAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
povidonesINACTIVE INGREDIENTFZ989GH94EAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RAFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MSD CONSUMER CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1167AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BAYER HEALTHCARE LLC.]11Current NDC, Legacy NDC, 11 package rows20241208_89c165ba-3ad5-49b5-a5bb-423dc8e15bad.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 61 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
application number: M012
Complete Allergy MedicineDIPHENHYDRAMINE HCLSalado Sales, Inc.c0f5c8ca-b187-40bf-9245-6a29f1c32c972026-01-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000992Afrin 0.05 % Nasal SprayPSN89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000992Afrin 0.05 % Nasal SpraySY89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000992Afrin 0.5 MG/ML Nasal SpraySY89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY89c165ba-3ad5-49b5-a5bb-423dc8e15bad12
1000992Afrin 0.05 % Nasal SprayPSN65bf1556-f234-9439-e053-2a91aa0a31945
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN65bf1556-f234-9439-e053-2a91aa0a31945
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD65bf1556-f234-9439-e053-2a91aa0a31945
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD65bf1556-f234-9439-e053-2a91aa0a31945
1000992Afrin 0.05 % Nasal SpraySY65bf1556-f234-9439-e053-2a91aa0a31945
1000992Afrin 0.5 MG/ML Nasal SpraySY65bf1556-f234-9439-e053-2a91aa0a31945
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY65bf1556-f234-9439-e053-2a91aa0a31945
1000992Afrin 0.05 % Nasal SprayPSN1387514f-3c4b-46d0-873c-9eedf97213273
1000992Afrin 0.05 % Nasal SprayPSNaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN1387514f-3c4b-46d0-873c-9eedf97213273
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBDaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD1387514f-3c4b-46d0-873c-9eedf97213273
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1387514f-3c4b-46d0-873c-9eedf97213273
1000992Afrin 0.05 % Nasal SpraySYaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000992Afrin 0.05 % Nasal SpraySY1387514f-3c4b-46d0-873c-9eedf97213273
1000992Afrin 0.5 MG/ML Nasal SpraySY1387514f-3c4b-46d0-873c-9eedf97213273
1000992Afrin 0.5 MG/ML Nasal SpraySYaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY1387514f-3c4b-46d0-873c-9eedf97213273
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYaf46c67d-f01f-83f8-e053-2a95a90aa70f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-1167-1115231167016 mL in 1 BOTTLE, SPRAY (11523-1167-1) 6 ml2022-11-160000-00-00NoNoCurrent
11523-1167-2115231167022 BOTTLE, SPRAY in 1 CARTON (11523-1167-2) / 21 mL in 1 BOTTLE, SPRAY1975-07-140000-00-00NoNoCurrent
11523-1167-3115231167031 BOTTLE, SPRAY in 1 CARTON (11523-1167-3) / 20 mL in 1 BOTTLE, SPRAY1975-07-140000-00-00NoNoCurrent
11523-1167-4115231167043 BOTTLE, SPRAY in 1 CARTON (11523-1167-4) > 30 mL in 1 BOTTLE, SPRAY1975-07-140000-00-00NoNoCurrent
11523-1167-5115231167051 BOTTLE, SPRAY in 1 CARTON (11523-1167-5) / 30 mL in 1 BOTTLE, SPRAY1975-07-140000-00-00NoNoCurrent
11523-1167-6115231167061 BOTTLE, SPRAY in 1 CARTON (11523-1167-6) / 15 mL in 1 BOTTLE, SPRAY1975-07-140000-00-00NoNoCurrent