FDA.reportPublic FDA data

Afrin No Drip

Product NDC
11523-1350
11-digit product format
115231350
Labeler code
11523
Product ID
11523-1350_4536ec8c-2a12-84b7-e063-6294a90a24ba
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Bayer HealthCare LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-08-31
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

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 No Drip
Brand name suffix
Severe Congestion
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
a79b5541-864b-412a-a085-96986ed6af59Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

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 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

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

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 SprayPSNa79b5541-864b-412a-a085-96986ed6af5914
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa79b5541-864b-412a-a085-96986ed6af5914
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBDa79b5541-864b-412a-a085-96986ed6af5914
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa79b5541-864b-412a-a085-96986ed6af5914
1000992Afrin 0.05 % Nasal SpraySYa79b5541-864b-412a-a085-96986ed6af5914
1000992Afrin 0.5 MG/ML Nasal SpraySYa79b5541-864b-412a-a085-96986ed6af5914
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa79b5541-864b-412a-a085-96986ed6af5914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11523-1350-1115231350011 BOTTLE, PUMP in 1 CARTON (11523-1350-1) / 15 mL in 1 BOTTLE, PUMP2000-08-310000-00-00NoNoCurrent
11523-1350-2115231350022 BOTTLE, PUMP in 1 CARTON (11523-1350-2) / 20 mL in 1 BOTTLE, PUMP2000-08-310000-00-00NoNoCurrent
11523-1350-3115231350032 BOTTLE, PUMP in 1 CARTON (11523-1350-3) / 15 mL in 1 BOTTLE, PUMP2022-12-020000-00-00NoNoCurrent
11523-1350-4115231350043 BOTTLE, PUMP in 1 CARTON (11523-1350-4) / 20 mL in 1 BOTTLE, PUMP2022-12-020000-00-00NoNoCurrent