FDA.reportPublic FDA data

nasal

Product NDC
41250-304
11-digit product format
412500304
Labeler code
41250
Product ID
41250-304_55abbd41-0eaa-48d9-823e-83b09096dab1
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-12-06
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
nasal
Brand name suffix
12 hour
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9ee03db-a070-4c2b-ac61-7fd22bab2795Available 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
41250-304-10nasal12 hour1 in 1 CARTONSPRAY16
41250-304-10nasal12 hour30 mL in 1 BOTTLE, SPRAYSPRAY306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2
WATERINACTIVE INGREDIENT059QF0KO0RNASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-304NASAL 12 HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 2 package rows20240912_e9ee03db-a070-4c2b-ac61-7fd22bab2795.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 59 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapo SteamVAPO STEAMTOPCO ASSOCIATES, LLCf216f69f-9580-25ac-e053-2995a90a5ac62026-01-14WarningsExact identifier
application number: M012
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
application number: M012
Sinus PE plus AllergyCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLWalgreen Companya15979d4-87bf-42e7-b1f2-7834960721412026-01-13WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.4260542e-0980-4b0b-8177-1c9f2c53b5a62026-01-13WarningsExact identifier
application number: M012
Sweet ComfortMENTHOLSaje Natural Business Inc.cf13cccd-723d-4d61-8a5e-b36281605cc72026-01-13WarningsExact identifier
application number: M012
FortifyMENTHOLSaje Natural Business Inc.0320a305-99d1-4909-94cc-cd6509ecb9482026-01-13WarningsExact identifier
application number: M012
Rolling FarmacyMENTHOLSaje Natural Business Inc.a38765a9-22cd-4fc5-b5ab-c3cacbd52c742026-01-13WarningsExact identifier
application number: M012
Home FarmacyMENTHOLSaje Natural Business Inc.add35d10-b27a-4ae8-b2de-8a285aaef1552026-01-13WarningsExact identifier
application number: M012
Traveling FarmacyMENTHOLSaje Natural Business Inc.5b70f5aa-ed36-65ab-e053-2a91aa0a67772026-01-13WarningsExact identifier
application number: M012
sinus plus allergy PE maximum strengthCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI660d3c80-f249-41dd-aa93-a0b1e635ead02026-01-13WarningsExact identifier
application number: M012
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLH E Bc9e977b6-fba6-49ea-9d80-b43b0842bbe12026-01-12WarningsExact identifier
application number: M012
PE Sinus CongestionPHENYLEPHRINE HCLTopco Associates, LLC3264e291-7a0f-4e25-8390-ba441f22f6502026-01-12WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACY3f44cff6-240a-4a8d-aaa1-0da75a31a47b2026-01-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus Congestion Non-DrowsyPHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEb9122fd0-0bed-4302-9bbe-cd6a46d298182026-01-12WarningsExact identifier
application number: M012
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
application number: M012
SU PHEDRINE PE SINUS CONGESTIONPHENYLEPHRINE HCLSalado Sales, Inc.ba075ff7-4e26-4856-8335-0c7dd4e198ea2026-01-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNe9ee03db-a070-4c2b-ac61-7fd22bab27956
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDe9ee03db-a070-4c2b-ac61-7fd22bab27956
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYe9ee03db-a070-4c2b-ac61-7fd22bab27956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-304-10412500304101 BOTTLE, SPRAY in 1 CARTON (41250-304-10) / 30 mL in 1 BOTTLE, SPRAY1991-12-060000-00-00NoNoCurrent