FDA.reportPublic FDA data

Femmesil

Product NDC
24909-202
Requested package NDC
24909-202-29
11-digit product format
249090202
Labeler code
24909
Product ID
24909-202_3d36573c-47d1-d5b2-e063-6394a90ac314
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aidance Skincare & Topical Solutions, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-07
Marketing end
2027-06-13
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
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
Femmesil
Brand name suffix
Maximum Strength

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
1535160Internal RxNorm lookup
1542929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8b01fe1-4465-497b-909e-f51f31fdf833Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-202-28FemmesilMaximum Strength1 in 1 CARTONOINTMENT15
24909-202-28FemmesilMaximum Strength28 g in 1 BOTTLEOINTMENT285
24909-202-29FemmesilMaximum Strength28 g in 1 TUBEOINTMENT285

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
MICONAZOLEACTIVE MOIETY7NNO0D7S5MFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
SILVER OXIDEINACTIVE INGREDIENT897WUN6G6TFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZFEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-202FEMMESIL MAXIMUM STRENGTH (MICONAZOLE NITRATE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]4Current NDC, Legacy NDC, 3 package rows20240604_d8b01fe1-4465-497b-909e-f51f31fdf833.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 44 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
application number: M005
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
application number: M005
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
application number: M005
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
application number: M005
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
application number: M005
MICONAZOLE NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
application number: M005
AntifungalTOLNAFTATE 1%Chain Drug Marketing Association Inc.26303499-dc58-f417-e063-6394a90a0a1b2024-11-05WarningsExact identifier
application number: M005
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
application number: M005
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
application number: M005
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
application number: M005
Micomitin AntifungalTOLNAFTATEPureTek Corporationde9842ba-0254-8ae1-e053-2995a90a06642024-10-16WarningsExact identifier
application number: M005
Ongo - FinTOLNAFTATEEfficient Laboratories Inc.bb5fb71f-bee0-42fa-9c9f-6231b555324c2024-10-14WarningsExact identifier
application number: M005
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542929Femmesil 2 % Vaginal OintmentPSNd8b01fe1-4465-497b-909e-f51f31fdf8335
1535160miconazole nitrate 2 % Vaginal OintmentPSNd8b01fe1-4465-497b-909e-f51f31fdf8335
1542929miconazole nitrate 0.02 MG/MG Vaginal Ointment [Femmesil]SBDd8b01fe1-4465-497b-909e-f51f31fdf8335
1535160miconazole nitrate 0.02 MG/MG Vaginal OintmentSCDd8b01fe1-4465-497b-909e-f51f31fdf8335
1542929Femmesil 0.02 MG/MG Vaginal OintmentSYd8b01fe1-4465-497b-909e-f51f31fdf8335
1535160miconazole nitrate 2 % Vaginal OintmentSYd8b01fe1-4465-497b-909e-f51f31fdf8335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24909-202-292490902022928 g in 1 TUBE (24909-202-29) 28 g2018-12-312027-06-13NoNoCurrent