FDA.reportPublic FDA data

Nasal

Product NDC
30142-304
11-digit product format
301420304
Labeler code
30142
Product ID
30142-304_f8333756-11de-4e59-bb6d-66b94c0755fd
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Kroger Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-11-15
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
6499f854-2995-48cb-9c80-be6524b3db43Available 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
30142-304-10Nasal30 mL in 1 BOTTLESPRAY308
30142-304-10Nasal1 in 1 CARTONSPRAY18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-304-10ML - Milliliter30142-304b3aea1aa-a381-4231-a6ca-e45c107fc14f12014-10-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-304NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [KROGER COMPANY]7Current NDC, Legacy NDC, 2 package rows20240921_6499f854-2995-48cb-9c80-be6524b3db43.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 58 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pocket FarmacyMENTHOLSaje Natural Business Inc.bdc15c6f-73b4-488e-9134-e70565df71bb2026-01-14WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
application number: M012
Rite Aid Pharmacy congestion relief vaporizing steamVAPORIZING STEAMRite Aid Pharmacy0fb86b23-0313-8fd8-e063-6394a90a0f5f2026-01-14WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN6499f854-2995-48cb-9c80-be6524b3db438
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD6499f854-2995-48cb-9c80-be6524b3db438
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY6499f854-2995-48cb-9c80-be6524b3db438

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-304-10301420304101 BOTTLE in 1 CARTON (30142-304-10) / 30 mL in 1 BOTTLE1 bottle1990-11-150000-00-00NoNoCurrent