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 90 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC15b3de6c-7ccc-408b-8789-d0e2f21a88352025-11-12WarningsExact identifier
application number: M012
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
application number: M012
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
application number: M012
DESGEN DMDEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCLKramer Novis6ab47174-e1fd-47ce-8788-06b7cdad52182025-11-12WarningsExact identifier
application number: M012
PresgenGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novisedad7a86-0d27-4a98-85b2-4b6725904f282025-11-12WarningsExact identifier
application number: M012
TUSSI PRES PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVISb01a45df-3cea-4729-80c1-7f35b7f707f02025-11-12WarningsExact identifier
application number: M012
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
application number: M012
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
application number: M012
TOPCARE Childrens Cold and Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDETopco Associates, LLC8931d4ca-c599-49be-87e1-8c0598f38b772025-11-11WarningsExact identifier
application number: M012
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact 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