FDA.reportPublic FDA data

nasal mist

Product NDC
59779-388
11-digit product format
597790388
Labeler code
59779
Product ID
59779-388_a863b440-d02d-472b-873e-5561dc8eadbb
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-09-04
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 mist
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
b71c557a-eb93-40d1-87c4-847f5468fc1eAvailable 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
59779-388-10nasal mist1 in 1 CARTONSPRAY, METERED16
59779-388-10nasal mist30 mL in 1 BOTTLE, PUMPSPRAY, METERED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-388-10ML - Milliliter59779-3883a4f3e90-88d6-4939-944b-85bd4c4f63e412018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3
WATERINACTIVE INGREDIENT059QF0KO0RNASAL MIST (OXYMETAZOLINE HCL) SPRAY [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-388NASAL MIST (OXYMETAZOLINE HCL) SPRAY, METERED [CVS PHARMACY]6Current NDC, Legacy NDC, 2 package rows20240906_b71c557a-eb93-40d1-87c4-847f5468fc1e.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNb71c557a-eb93-40d1-87c4-847f5468fc1e6
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDb71c557a-eb93-40d1-87c4-847f5468fc1e6
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYb71c557a-eb93-40d1-87c4-847f5468fc1e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-388-10597790388101 BOTTLE, PUMP in 1 CARTON (59779-388-10) / 30 mL in 1 BOTTLE, PUMP2002-09-040000-00-00NoNoCurrent