FDA.reportPublic FDA data

Micro-Guard

Product NDC
11701-038
11-digit product format
117010038
Labeler code
11701
Product ID
11701-038_ecd660df-c2f6-4a4c-b878-4451869d9770
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Coloplast Corp
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
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
Micro-Guard
Brand name suffix
(AF)
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998461Internal RxNorm lookup
998469Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a43a94d0-fec0-470f-bdb4-535dcce6d1e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-038-162023-12-15C16284748780-1f386c649-a446-0266-e053-dadaa90a7c1aMicro-Guard ® Powder Antifungal Powder With Miconazole Nitrate 2%
11701-038-162023-01-30C16284748780-1f386c649-a446-0266-e053-dadaa90a7c1aMicro-Guard ® Powder Antifungal Powder With Miconazole Nitrate 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-038-16Micro-Guard(AF)85 g in 1 BOTTLEPOWDER858

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-038-16GM - Gram11701-0385caa278f-1182-4ab9-bb46-9aa6bfb984bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]4
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOMICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]4
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28MICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-038MICRO-GUARD (AF) (MICONAZOLE NITRATE) POWDER [COLOPLAST MANUFACTURING US, LLC]7Current NDC, Legacy NDC, 1 package rows20231216_a43a94d0-fec0-470f-bdb4-535dcce6d1e0.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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
application number: M005
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNa43a94d0-fec0-470f-bdb4-535dcce6d1e08
998469Micro-Guard 2 % Topical PowderPSNa43a94d0-fec0-470f-bdb4-535dcce6d1e08
998469miconazole nitrate 0.02 MG/MG Topical Powder [Micro-Guard]SBDa43a94d0-fec0-470f-bdb4-535dcce6d1e08
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDa43a94d0-fec0-470f-bdb4-535dcce6d1e08
998461miconazole nitrate 2 % Topical PowderSYa43a94d0-fec0-470f-bdb4-535dcce6d1e08
998469Micro-Guard 0.02 MG/MG Topical PowderSYa43a94d0-fec0-470f-bdb4-535dcce6d1e08
998469Micro-Guard 2 % Topical PowderSYa43a94d0-fec0-470f-bdb4-535dcce6d1e08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-038-161170100381685 g in 1 BOTTLE (11701-038-16) 85 g2009-06-150000-00-00NoNoCurrent