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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
application number: M005
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
application number: M005
FFPMAM Antifungal CreamFFPMAM ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd57b7cf61-d4cd-53f7-e063-6394a90afc542026-07-28WarningsExact identifier
application number: M005
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-07-27WarningsExact identifier
application number: M005
antifungal penANTIFUNGAL PENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5756256e-ed2b-4e13-e063-6294a90a1e0f2026-07-24WarningsExact identifier
application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
application number: M005
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
application number: M005
HTRCSW FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523bc484-511c-b603-e063-6394a90a55ae2026-07-21WarningsExact identifier
application number: M005
DERMFREE ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD49ab5abb-d311-505d-e063-6294a90a56162026-07-21WarningsExact identifier
application number: M005
DERMFREE FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD49aba00d-9249-b403-e063-6394a90a787d2026-07-21WarningsExact identifier
application number: M005
SKAPEMED SKIN REPAIRTOLNAFTATE 1% SKIN REPAIRJiangxi Yudexi Pharmaceutical Co., LTD4a20c32e-0551-aead-e063-6394a90a2aa72026-07-21WarningsExact identifier
application number: M005
REINREUDE MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a380945-9235-783a-e063-6294a90a094d2026-07-21WarningsExact identifier
application number: M005
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005

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

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