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
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
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 72 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact identifier
application number: M012
Nighttime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE029e6215-b72d-4fd0-8918-db1abcc4490a2025-12-19WarningsExact identifier
application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE5f680f37-b3db-450f-b8ca-f9e31a04dc042025-12-19WarningsExact 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