equate nasal

Product NDC
49035-304
11-digit product format
490350304
Labeler code
49035
Product ID
49035-304_bac4a212-e4c2-4da7-acc1-3e5c6e6afa21
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-08-15
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
Brand name suffix
original
Listing expiration
2027-12-31

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
7e40c9b8-e0b5-448a-a674-72388fbab189Available 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
49035-304-10equate nasaloriginal30 mL in 1 BOTTLE, SPRAYSPRAY305
49035-304-10equate nasaloriginal1 in 1 CARTONSPRAY15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-304-10ML - Milliliter49035-3046c807c39-11e5-4482-815a-c7603b16294a12013-10-17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-304EQUATE NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WAL-MART STORES INC]5Current NDC, Legacy NDC, 2 package rows20240912_7e40c9b8-e0b5-448a-a674-72388fbab189.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 170 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012
AXIM DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC0e7424ea-461f-5ead-e063-6294a90a41b62024-01-05WarningsExact identifier
application number: M012
AXIM Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC0e740063-80d5-c48b-e063-6394a90a3b302024-01-05WarningsExact identifier
application number: M012
AXIM DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC0e742e10-daea-6443-e063-6294a90ab5af2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3c3e0dc8-cddd-4f46-9b68-19bac00c07cc2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLA-S Medication Solutionsfa12a5a8-bf2d-4991-9d54-9c519e8e04cd2024-01-04WarningsExact identifier
application number: M012
NASAL DECONGESTANT PE 10mgPHENYLPHRINE HCLYYBA CORP05824fc4-ef3f-4ebb-b601-252f76ad60ef2024-01-03WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP5943d975-77e4-4cbd-b2d9-d699052fe82a2024-01-01WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEProficient Rx LPac79a7dd-c26e-47d2-8fb9-768d2d09e5072024-01-01WarningsExact identifier
application number: M012
Oxymethazoline HCLOXYMETHAZOLINE HCLProficient Rx LP96883e5f-18b5-4c1c-b984-756cb86be6ff2024-01-01WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP6e91b9c3-57e8-488b-ac70-d863cdf9d6e82024-01-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LP9e067482-8735-4476-a82e-438dd24d42892024-01-01WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.94e02be4-b8a6-422a-8f66-e6a69e924b2c2023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDEAptaPharma Inc.8a4c55d0-c472-4e89-9fdb-17ecf0af48562023-12-30WarningsExact identifier
application number: M012
XL-3 XtremeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAptaPharma Inc.dff79e0b-edf0-4dd3-a722-fd9beecd62932023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSalado Sales, Inc.e25727d0-7dd7-4ef5-b064-7938679f075f2023-12-29WarningsExact identifier
application number: M012
Maximum Strength DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E Bbb56d09d-ecb0-469e-a16f-f9f1a48942a82023-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN7e40c9b8-e0b5-448a-a674-72388fbab1895
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD7e40c9b8-e0b5-448a-a674-72388fbab1895
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY7e40c9b8-e0b5-448a-a674-72388fbab1895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-304-10490350304101 BOTTLE, SPRAY in 1 CARTON (49035-304-10) / 30 mL in 1 BOTTLE, SPRAY1990-08-150000-00-00NoNoCurrent