FDA.reportPublic FDA data

HUA TUO XIAN GAO ANTIFUNGAL

Product NDC
55614-650
11-digit product format
556140650
Labeler code
55614
Product ID
55614-650_4346d216-107c-3420-e063-6294a90a7fcb
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
OINTMENT
Route
TOPICAL
Labeler
MADISON ONE ACME INC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-01
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
HUA TUO XIAN GAO ANTIFUNGAL
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
418475Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1dAvailable 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-650-01HUA TUO XIAN GAO ANTIFUNGAL20 g in 1 TUBEOINTMENT203
55614-650-01HUA TUO XIAN GAO ANTIFUNGAL1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55614-650HUA TUO XIAN GAO ANTIFUNGAL (CLOTRIMAZOLE) OINTMENT [MADISON ONE ACME INC]2Current NDC, Legacy NDC, 2 package rows20241127_e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d.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 33 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
application number: M005
SKIN TAG WART AND CORN REMOVERSALICYLIC ACIDZhenping Renren Industry Co., Ltd.3e6dad69-b301-f7dc-e063-6394a90ad3802025-09-14WarningsExact identifier
application number: M005
FUNGAL NAILS REPAIRING ESSENCEPEPPERMINT OILZhenping Renren Industry Co., Ltd.3e82649c-d784-d64c-e063-6294a90ac95d2025-09-11WarningsExact identifier
application number: M005
equate Athletes FootTOLNAFTATEWal-Mart Stores Ince90297d0-0f87-4ae3-b9b7-959266d57c242025-09-11WarningsExact identifier
application number: M005
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.3e7d22b0-2f57-fcac-e063-6394a90aefd92025-09-10WarningsExact identifier
application number: M005
Amerfresh Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltdcdc4f0ff-07bd-47c8-850b-1698308bb6602025-09-09WarningsExact identifier
application number: M005
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
application number: M005
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
application number: M005
Extra Strength Nail Fungus TreatmentUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abc0892-e52b-a40f-e063-6294a90a0e352025-09-02WarningsExact identifier
application number: M005
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
application number: M005
CaseysBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.a29d6c19-01aa-45b0-92cd-3f1148bad4f82025-08-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREEVALU MERCHANDISERS, CO.1d258684-9034-460c-953d-78e2b51981672025-08-26WarningsExact identifier
application number: M005
Femmesil Maximum StrengthMICONAZOLE NITRATEAidance Skincare & Topical Solutions, LLCd8b01fe1-4465-497b-909e-f51f31fdf8332025-08-25WarningsExact identifier
application number: M005
femmesil Ultra TherapyCLOTRIMAZOLEAidance Scientific, Inc.3d36794a-07d0-860c-e063-6294a90a6e8f2025-08-25WarningsExact identifier
application number: M005
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLC6b74d405-42d6-4c46-ba78-3007d1e8ffb82025-08-23WarningsExact identifier
application number: M005
FUNGLARA Anti FungalUNDECYLENIC ACIDFUNGLARA LLCa23c2399-36ea-4f22-8140-066e22c9a8622025-08-20WarningsExact identifier
application number: M005
Rapid MicroGelTOLNAFTATEThe Tetra Corporationafb6d7c4-1f75-4694-83c8-d6469250d6a12025-08-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
418475clotrimazole 1 % Topical OintmentPSNe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d3
418475clotrimazole 0.01 MG/MG Topical OintmentSCDe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d3
418475clotrimazole 1 % Topical OintmentSYe11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55614-650-01556140650011 TUBE in 1 BOX (55614-650-01) / 20 g in 1 TUBE1 tube2020-04-010000-00-00NoNoCurrent