FDA.reportPublic FDA data

Rugby Clotrimazole Antifungal Cream

Product NDC
0536-1265
11-digit product format
005361265
Labeler code
0536
Product ID
0536-1265_29b43e9e-352d-2018-e063-6394a90a27f7
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-19
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
Rugby Clotrimazole Antifungal Cream
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
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1365bc7-b376-adca-e053-2a95a90acf19Available 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
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1265-11Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM15
0536-1265-11Rugby Clotrimazole Antifungal Cream14.17 g in 1 TUBECREAM14.175
0536-1265-26Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM15
0536-1265-26Rugby Clotrimazole Antifungal Cream45 g in 1 TUBECREAM455
0536-1265-95Rugby Clotrimazole Antifungal Cream1 in 1 BOXCREAM15
0536-1265-95Rugby Clotrimazole Antifungal Cream28 g in 1 TUBECREAM285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1265-11GM - Gram0536-12652c40d8cc-1769-4905-bac0-fb8d74d4f8a012024-05-16
0536-1265-26GM - Gram0536-126507291e9c-7da9-43e7-acb6-313ea812fd7212020-08-06
0536-1265-95GM - Gram0536-1265751a2bf8-e819-4298-90c5-4cc32e82ba9d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1265RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20241222_a1365bc7-b376-adca-e053-2a95a90acf19.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 8 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
application number: M005
VORVITA Nail HardenerPANTHENOL,HYALURONIC ACIDHK Vorvita Technology Co., Limited51d5d3c7-ca25-3ee5-e063-6294a90a3a052026-06-26WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNa1365bc7-b376-adca-e053-2a95a90acf195
309367clotrimazole 10 MG/ML Topical CreamSCDa1365bc7-b376-adca-e053-2a95a90acf195
309367clotrimazole 1 % Topical CreamSYa1365bc7-b376-adca-e053-2a95a90acf195
309367clotrimazole 1 % Topical CreamPSNbd567e91-7152-4612-83e0-8e8a00c2d2c51
309367clotrimazole 10 MG/ML Topical CreamSCDbd567e91-7152-4612-83e0-8e8a00c2d2c51
309367clotrimazole 1 % Topical CreamSYbd567e91-7152-4612-83e0-8e8a00c2d2c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1265-11005361265111 TUBE in 1 BOX (0536-1265-11) / 14.17 g in 1 TUBE1 tube2023-11-20NoNoCurrent
0536-1265-26005361265261 TUBE in 1 BOX (0536-1265-26) / 45 g in 1 TUBE1 tube2020-03-190000-00-00NoNoCurrent
0536-1265-95005361265951 TUBE in 1 BOX (0536-1265-95) / 28 g in 1 TUBE1 tube2023-11-20NoNoCurrent