FDA.reportPublic FDA data

nasal

Product NDC
41250-388
11-digit product format
412500388
Labeler code
41250
Product ID
41250-388_d8626005-e7bc-47b2-9c1e-763f35873bf1
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-09-11
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
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
3984cbc3-b60c-40a7-bc3a-7d1f600503acAvailable 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-388-10nasal30 mL in 1 BOTTLE, SPRAYSPRAY, METERED305
41250-388-10nasal1 in 1 CARTONSPRAY, METERED15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2
WATERINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HCL) SPRAY [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-388NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [MEIJER DISTRIBUTION INC]5Current NDC, Legacy NDC, 2 package rows20240906_3984cbc3-b60c-40a7-bc3a-7d1f600503ac.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 129 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC5372f764-985e-4a42-bc97-cb0dc90fcd9c2024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTOPCO ASSOCIATES LLC5a2d0464-038d-4c3f-b39e-ee9984fb383e2024-12-18WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINValu Mercha72b6a97-f97f-44bb-8d55-ac48b8ba45c52024-12-18WarningsExact identifier
application number: M012
Harris Teeter Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter4ebe1d94-bb15-4250-a4c2-8cd45743c7dd2024-12-18WarningsExact identifier
application number: M012
Care One Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRETAIL BUSINESS SERVICES , LLCf6657dee-9f32-45b1-8e44-1ad67a4a68bd2024-12-18WarningsExact identifier
application number: M012
Childrens Metapp DaytimeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLGuardian Drug Company40565500-944b-47f2-8563-5df05469e4182024-12-18WarningsExact identifier
application number: M012
CVS Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCVS Pharmacy, Inc.884abed2-e355-4134-92f1-591f3a18f71d2024-12-18WarningsExact identifier
application number: M012
CVS Health Chest Congestion Relief PEGUAIFENESIN/PHENYLEPHRINECVS Pharmacy, Inc.a49020e8-739e-47ec-8141-e866479a3ab32024-12-18WarningsExact identifier
application number: M012
Family Wellness Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINFamily Dollar Services Inc8aee8108-a4e0-4956-8e37-6b3b1c5dc6832024-12-18WarningsExact identifier
application number: M012
TopCare Chest Congestion ReliefGUAIFENESINTOPCO ASSOCIATES LLCb8339617-17ce-4ad7-af38-399ecc74d8642024-12-18WarningsExact identifier
application number: M012
Kroger Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETHE KROGER CO976bfdcf-2110-486c-aa6e-cd2067334cdc2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINAmerisourceBergen Drug Corp79cefd46-bd19-4a1d-9cb1-e85ff0f124942024-12-18WarningsExact identifier
application number: M012
Leader Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINCardinal Health8397e1b9-e83e-4c6a-b858-1663c23658402024-12-18WarningsExact identifier
application number: M012
GNP Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEAmerisourceBergen Drug Corp63932e68-b09d-4500-bc1d-cfb2c267df1c2024-12-18WarningsExact identifier
application number: M012
Meijer Chest Congestion ReliefGUAIFENESINMeijer Distribution Inc.ae02e0bd-d9e7-495f-b01f-b135b96934a02024-12-18WarningsExact identifier
application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PEGUAIFENESIN/PHENYLEPHRINETOPCO ASSOCIATES LLCb6c0362f-86ca-4f08-ba53-800c6df2c0252024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINStrategic Sourcing Services LLC10cad9a7-1223-470c-9027-807891217d402024-12-18WarningsExact identifier
application number: M012
Kroger Mucus ReliefGUAIFENESINTHE KROGER CO2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e2024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Association41f88b43-3e0a-4650-b167-a72afe6177e82024-12-18WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINRugby Laboratories5da36516-9f94-49cb-9421-0c310abcd1162024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3984cbc3-b60c-40a7-bc3a-7d1f600503ac5
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3984cbc3-b60c-40a7-bc3a-7d1f600503ac5
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3984cbc3-b60c-40a7-bc3a-7d1f600503ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-388-10412500388101 BOTTLE, SPRAY in 1 CARTON (41250-388-10) / 30 mL in 1 BOTTLE, SPRAY2002-09-110000-00-00NoNoCurrent