FDA.reportPublic FDA data

THERA Antifungal Body

Product NDC
68599-0207
11-digit product format
685990207
Labeler code
68599
Product ID
68599-0207_1adaf2c5-f6a7-7cde-e063-6294a90af8d6
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
McKesson Medical-Surgical Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-09-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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
THERA Antifungal Body
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31096041-28c9-4b16-bbd1-dbadefd37505Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0207-3THERA Antifungal Body85 g in 1 BOTTLE, PLASTICPOWDER856

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68599-0207-3GM - Gram68599-02072865e793-a52c-49f3-912d-03026824055112023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8THERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4THERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTHERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0207THERA ANTIFUNGAL BODY (MICONAZOLE NITRATE) POWDER [MCKESSON MEDICAL-SURGICAL INC.]6Current NDC, Legacy NDC, 1 package rows20240616_31096041-28c9-4b16-bbd1-dbadefd37505.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 18 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsExact identifier
application number: M005
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriese21ccb83-54ff-4605-80bf-7b4b789c7cb72026-03-17WarningsExact identifier
application number: M005
Peunitory Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.4d2e86bc-5122-ba4a-e063-6394a90acf132026-03-16WarningsExact identifier
application number: M005
DRMITSUI FOOT ANTIFUNGAL TREATMENTSALICYLIC ACIDZhenping Renren Industry Co., Ltd.4ce59d31-56fe-d74f-e063-6294a90a7cce2026-03-14WarningsExact identifier
application number: M005
NERANTE FUNGUS NAIL PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3984b-53cd-a665-e063-6394a90afe5f2026-03-13WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENTUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3f0e2-b532-b89f-e063-6294a90a7e252026-03-13WarningsExact identifier
application number: M005
BYT BANGYTONG HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShenzhen Jindali Technology Co., Ltd49ed1cc8-e8e5-399c-e063-6394a90a044a2026-03-10WarningsExact identifier
application number: M005
Natouch Antifungal Wipes PlusANTIFUNGAL ANTISEPTIC WIPES PLUSNatouch LLCa85cb307-b3ad-1584-e053-2995a90a9a702026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb6fdfd-116e-14e9-e063-6294a90a4de32026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b2026-03-10WarningsExact identifier
application number: M005
SootheSense Toenail Fungus TreatmentUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca2bbeb-3b8a-9482-e063-6294a90a57892026-03-09WarningsExact identifier
application number: M005
Natouch Antifungal Antiseptic WipesANTIFUNGAL ANTISEPTIC WIPESNatouch LLC4c84c556-8d0b-ec28-e063-6294a90af1d32026-03-08WarningsExact identifier
application number: M005
ANTIFUNGAL CreamANGELICA DAHURICA EXTRACTT, ASIATIC ACIDGuangzhou Mizi Biotechnology Co., LTD.4c586cd9-d356-34d8-e063-6294a90a4d112026-03-06WarningsExact identifier
application number: M005
FungiFoamTOLNAFTATEThe Tetra Corporation2449e8e5-9d7e-4119-9e7a-378efe55f8752026-03-06WarningsExact identifier
application number: M005
RoyceDerm ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4c43e62b-9060-8962-e063-6394a90aff632026-03-05WarningsExact identifier
application number: M005
Derman AntifungalTOLNAFTATECompania Internacional de Comercio, S.A.P.I. de C.V.5784a783-1056-4d50-8d87-2df4f8e16b092026-03-05WarningsExact identifier
application number: M005
Antifungal PowderTOLNAFTATEARMY & AIR FORCE EXCHANGE SERVICE4c39e121-4919-a482-e063-6294a90a98cd2026-03-04WarningsExact identifier
application number: M005
ViLLsure Antifungal PenUNDECYLENIC ACID 25%ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD4c28cf04-94ad-8db6-e063-6394a90a2eed2026-03-03WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN31096041-28c9-4b16-bbd1-dbadefd375056
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD31096041-28c9-4b16-bbd1-dbadefd375056
998461miconazole nitrate 2 % Topical PowderSY31096041-28c9-4b16-bbd1-dbadefd375056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0207-36859902070385 g in 1 BOTTLE, PLASTIC (68599-0207-3) 85 g2018-08-200000-00-00NoNoCurrent