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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe44d1ee-1e03-b74f-e053-6294a90a8bb42026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC325b41e1-f8d2-02ee-e063-6394a90aafff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6c85df30-a601-4de6-9fd6-818265d799ff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and Cool Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2ee95e17-bd94-d717-e063-6294a90a21732026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Sinus Pressure Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2eeafd83-230c-af92-e063-6294a90a984e2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
application number: M012
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
application number: M012
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, NightDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINWALMART INC.312ae879-1124-40a4-b2ba-3f30708400212026-05-19WarningsExact identifier
application number: M012
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact 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