FDA.reportPublic FDA data

fungoid tincture

Product NDC
0884-0293
Requested package NDC
0884-0293-01
11-digit product format
008840293
Labeler code
0884
Product ID
0884-0293_24ae5b13-853c-1311-e063-6394a90aa6ac
Type
HUMAN OTC DRUG
Nonproprietary name
miconazole nitrate
Dosage form
TINCTURE
Route
TOPICAL
Labeler
Pedinol Pharmacal, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-11
Substance
MICONAZOLE NITRATE
Active strength
20 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
fungoid tincture
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998525Internal RxNorm lookup
998526Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
250d0a66-01d1-4aba-8f24-4cb4ca529fdaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0884-0293-01fungoid tincture29.57 mL in 1 BOTTLE, WITH APPLICATORTINCTURE29.578
0884-0293-01fungoid tincture1 in 1 CARTONTINCTURE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0884-0293-01ML - Milliliter0884-0293c8854e7a-8786-48ac-91e1-b9ab9ded773112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
MiconazoleACTIVE MOIETY7NNO0D7S5MFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Acetic AcidINACTIVE INGREDIENTQ40Q9N063PFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Laureth-4INACTIVE INGREDIENT6HQ855798JFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0884-0293FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]8Current NDC, Legacy NDC, 2 package rows20241019_250d0a66-01d1-4aba-8f24-4cb4ca529fda.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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998526Fungoid 2 % tincture treatment kitPSN250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998525miconazole nitrate 2 % Topical SolutionPSN250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998526miconazole nitrate 20 MG/ML Topical Solution [Fungoid]SBD250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998525miconazole nitrate 20 MG/ML Topical SolutionSCD250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998526Fungoid 2 % Topical TinctureSY250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998526Fungoid 20 MG/ML Topical SolutionSY250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998525miconazole nitrate 2 % Topical SolutionSY250d0a66-01d1-4aba-8f24-4cb4ca529fda8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0884-0293-01008840293011 BOTTLE, WITH APPLICATOR in 1 CARTON (0884-0293-01) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR2012-04-110000-00-00NoNoCurrent