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
2027-12-31
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
2027-12-31

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 130 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTHE KROGER CO430c6604-93a7-4df6-a657-ba438aa614252024-12-18WarningsExact identifier
application number: M012
Discount Drugmart Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart, Inc1ac281e1-22ea-42f8-98fe-ab3d5ff9a2082024-12-18WarningsExact identifier
application number: M012
TopCare Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC4c50233e-1dcb-427d-ba63-1538cf3700612024-12-18WarningsExact identifier
application number: M012
Dollar General Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINDolgencorp, LLC718f08d2-3757-4f3e-915e-3e4982ad090f2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmerisourceBergen Drug Corpe4610d53-4459-43a0-9351-f0ac8586df602024-12-18WarningsExact identifier
application number: M012
Always Save Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEValu Merch5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f62024-12-17WarningsExact identifier
application number: M012
ChestrubCAMPHOR MENTHOL EUCALYPTUS OILDelta Brands Inc8e6f731f-c16a-41b2-9786-0cab588cfc8e2024-12-17WarningsExact identifier
application number: M012
Mentholatum Nighttime Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company5539ae74-9723-480d-b35f-0a6644bf54ad2024-12-17WarningsExact identifier
application number: M012
Mentholatum No Mess Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyf4675bc1-01cc-4a33-a3bf-bfc99230fe322024-12-17WarningsExact identifier
application number: M012
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact 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