FDA.reportPublic FDA data

femmesil Ultra Therapy

Product NDC
24909-050
11-digit product format
249090050
Labeler code
24909
Product ID
24909-050_3d36794a-07d1-860c-e063-6294a90a6e8f
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aidance Scientific, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-25
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
femmesil Ultra Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2722226Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d36794a-07d0-860c-e063-6294a90a6e8fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-050-28femmesil Ultra Therapy28 g in 1 TUBEOINTMENT281

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 39 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terrasil Anti-Fungal Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdb356cc8-f473-4eb2-b8d8-72606fca9dc02025-05-23WarningsExact identifier
application number: M005
terrasil Folliculitis Cream Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d54756-00dd-bbe1-e063-6394a90a9e022025-05-23WarningsExact identifier
application number: M005
Paume Moisturizing Antibacterial Hand GelALCOHOLPaume Incb6fe12bf-6430-5861-e053-2a95a90a6c8f2025-05-22WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATETrifecta Pharmaceuticals Usa Llc96a40ccd-17f7-4e4e-98da-207802fa2b2d2025-05-15WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATECardinal Health 110 dba LEADER34f4c733-2eb2-0db0-e063-6394a90a64312025-05-13WarningsExact identifier
application number: M005
Dr CANUSO fungal nail eraserTOLNAFTATE OILRenu Laboratories, LLC2083f9ed-09d6-26e6-e054-00144ff88e882025-05-13WarningsExact identifier
application number: M005
Dr. Canuso foot repair serumTOLNAFTATE SERUMRenu Laboratories, LLC1fcc52c5-7030-13cb-e054-00144ff8d46c2025-05-13WarningsExact identifier
application number: M005
Private Label Antifungal Barrier CreamMICONAZOLE NITRATE ANTIFUNGAL CREAMSwiss-American CDMO, LLC2ee40c37-504b-43ed-960a-5350154074922025-05-09WarningsExact identifier
application number: M005
Osimoon Fungal Nail Treatment KitOSIMOON FUNGAL NAIL TREATMENT KITGuangzhou Zanming Trading Co., Ltd.34aec10d-a0d0-d956-e063-6394a90a39b22025-05-09WarningsExact identifier
application number: M005
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC33d9c724-d4c4-2597-e063-6294a90aa5f32025-04-28WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEVIVE HEALTH LLC33db98f5-f6d9-742a-e063-6394a90a2a032025-04-28WarningsExact identifier
application number: M005
Foot Cure Nail Repair PenANTIFUNGAL NAIL REPAIR PENSANSAR, LLC9c823e27-8bb3-4ccd-bf7e-a99d45908e882025-04-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER CUCUMBER MELONALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380404d-9499-e9fb-e063-6394a90a0f272025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380fe6d-e059-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3381cefb-281c-9b85-e063-6294a90acfd92025-04-24WarningsExact identifier
application number: M005
Wish Hand Sanitizer Coconut Cream White FloralsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33826aef-6e50-2730-e063-6394a90a727b2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER GOLDEN CITRUSALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3391a78e-525d-c2ba-e063-6394a90a1e992025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33927939-a9dc-ab67-e063-6394a90a71cc2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA336c751f-6a33-ca55-e063-6394a90a97492025-04-23WarningsExact identifier
application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOODALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA337e4526-238a-bc2d-e063-6394a90a5a272025-04-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2722226clotrimazole 1 % Vaginal OintmentPSN3d36794a-07d0-860c-e063-6294a90a6e8f1
2722226clotrimazole 0.01 MG/MG Vaginal OintmentSCD3d36794a-07d0-860c-e063-6294a90a6e8f1
2722226clotrimazole 1 % Vaginal OintmentSY3d36794a-07d0-860c-e063-6294a90a6e8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24909-050-282490900502828 g in 1 TUBE (24909-050-28) 28 g2025-08-25NoNoCurrent