FDA.reportPublic FDA data

Equate Nasal

Product NDC
49035-388
11-digit product format
490350388
Labeler code
49035
Product ID
49035-388_0b25425e-adf3-41b8-8abd-fe77a300e551
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-07-27
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
Equate Nasal
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
c38a2783-aed9-466d-8976-59d03a792c04Available 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
49035-388-00Equate Nasal30 mL in 1 BOTTLE, SPRAYSPRAY, METERED306
49035-388-10Equate Nasal1 in 1 CARTONSPRAY, METERED16
49035-388-10Equate Nasal30 mL in 1 BOTTLE, SPRAYSPRAY, METERED306
49035-388-20Equate Nasal2 in 1 CARTONSPRAY, METERED26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-388-10ML - Milliliter49035-3884e1f7ef9-e49e-4fee-8d71-1b7b75ec183712013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74EQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWEQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUATE NASAL (OXYMETAZOLINE HCL) SPRAY [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-388EQUATE NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [WAL-MART STORES INC]5Current NDC, Legacy NDC, 4 package rows20240913_c38a2783-aed9-466d-8976-59d03a792c04.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 144 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
application number: M012
Careone daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAmerican Sales Company31187c98-6706-4962-91f6-022a390cda392024-10-28WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
application number: M012
Premier Value Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC46bf124a-a44f-4066-b936-852d46da8f402024-10-28WarningsExact identifier
application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway25a26577-a9f8-49cb-9d75-d8c471e4aaf62024-10-28WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e2024-10-28WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderd38537c6-9553-4e93-a83e-11ed48c955ab2024-10-28WarningsExact identifier
application number: M012
Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy2b3a1997-f382-4843-a44b-d80d1ad21a902024-10-28WarningsExact identifier
application number: M012
Premier Value Tussin Cough Long ActingDEXTROMETHORPHAN HBRChain Drug Consortium, LLC0e393287-5bb8-458b-98c4-55fa16674d062024-10-28WarningsExact identifier
application number: M012
daytime cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1740ccfc-6e68-46f4-a1ba-48fe092f0aa02024-10-28WarningsExact identifier
application number: M012
night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.d3bd0632-328c-4ad7-bb44-8383e1e51b8c2024-10-28WarningsExact identifier
application number: M012
Premier ValueDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC1ae3c6ac-1646-4c67-a9d5-9c383924b81a2024-10-28WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy1c341cf5-ac33-4a6e-b023-a23d280d496c2024-10-25WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyb6d9f421-b236-4660-be7f-85a878f2fc612024-10-25WarningsExact identifier
application number: M012
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEFACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLCf9c3c12b-4efa-4ec4-a156-c403aff817532024-10-24WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLC1deb60f3-e9be-4756-b0c1-527ef00dc7412024-10-24WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
application number: M012
Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC68a5930b-37db-439d-8fb9-7d7de07d84652024-10-24WarningsExact identifier
application number: M012
sinus pressure pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INCbb0225d5-6c32-2c64-e053-2995a90a829b2024-10-24WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC01e1ad15-0ef5-4d6a-a9c1-19a5f2b201482024-10-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNc38a2783-aed9-466d-8976-59d03a792c046
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDc38a2783-aed9-466d-8976-59d03a792c046
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYc38a2783-aed9-466d-8976-59d03a792c046

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-388-004903503880030 mL in 1 BOTTLE, SPRAY30 mlHistorical
49035-388-10490350388101 BOTTLE, SPRAY in 1 CARTON (49035-388-10) / 30 mL in 1 BOTTLE, SPRAY2007-07-270000-00-00NoNoCurrent
49035-388-20490350388202 BOTTLE, SPRAY in 1 CARTON (49035-388-20) / 30 mL in 1 BOTTLE, SPRAY (49035-388-00) 2025-07-07NoNoCurrent