FDA.reportPublic FDA data

MacerRx Web

Product NDC
44577-205
11-digit product format
445770205
Labeler code
44577
Product ID
44577-205_0973aae6-55b5-5f1a-e063-6394a90a9848
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-06
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MacerRx Web
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

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
998483Internal RxNorm lookup
1425866Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9327f41-10f1-41f3-855b-838c701d6767Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-205-56MacerRx Web1 in 1 CARTONCREAM15
44577-205-56MacerRx Web56 g in 1 TUBECREAM565

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RMACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-205MACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231106_c9327f41-10f1-41f3-855b-838c701d6767.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 1 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
Radthary GROIN ANTIFUNGAL CreamMICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1945f3-84ba-f3dc-e063-6294a90ab8a02026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
HSENJT Antifungal CreamMICONAZOLE NITRATEHuizhou Haosen Trading Co., Ltd.5aa587f5-5ddf-542a-e063-6294a90a522b2026-09-07WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
AOUGK SALICYLIC ACID WART REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5ac88b51-b46c-5cc6-e063-6394a90af9e52026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1425866MacerRx 2 % Topical CreamPSNc9327f41-10f1-41f3-855b-838c701d67675
998483miconazole nitrate 2 % Topical CreamPSNc9327f41-10f1-41f3-855b-838c701d67675
1425866miconazole nitrate 20 MG/ML Topical Cream [MacerRx]SBDc9327f41-10f1-41f3-855b-838c701d67675
998483miconazole nitrate 20 MG/ML Topical CreamSCDc9327f41-10f1-41f3-855b-838c701d67675
1425866MacerRx 2 % Topical CreamSYc9327f41-10f1-41f3-855b-838c701d67675
1425866MacerRx 20 MG/ML Topical CreamSYc9327f41-10f1-41f3-855b-838c701d67675
998483miconazole nitrate 2 % Topical CreamSYc9327f41-10f1-41f3-855b-838c701d67675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44577-205-56445770205561 TUBE in 1 CARTON (44577-205-56) / 56 g in 1 TUBE1 tube2017-02-060000-00-00NoNoCurrent