FDA.reportPublic FDA data

RUGBY ANTIFUNGAL CLOTRIMAZOLE

Product NDC
0536-1272
11-digit product format
005361272
Labeler code
0536
Product ID
0536-1272_2a90048a-67fe-47ae-ab8b-db872b5e1fda
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-14
Marketing end
2027-03-31
Substance
CLOTRIMAZOLE
Active strength
.01 g/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0536-1272UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-12720536-1272-22UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-12720536-1272-11UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 ANTIFUNGAL CLOTRIMAZOLE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE.01 g/g

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
0b32a369-ea1c-4cb8-8ea1-07bba8f16b72Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1272-11RUGBY ANTIFUNGAL CLOTRIMAZOLE1 in 1 CARTONCREAM14
0536-1272-11RUGBY ANTIFUNGAL CLOTRIMAZOLE14 g in 1 TUBECREAM144
0536-1272-22RUGBY ANTIFUNGAL CLOTRIMAZOLE1 in 1 CARTONCREAM14
0536-1272-22RUGBY ANTIFUNGAL CLOTRIMAZOLE28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1272RUGBY ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [RUGBY]3Current NDC, Legacy NDC, 4 package rows20250117_0b32a369-ea1c-4cb8-8ea1-07bba8f16b72.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 40 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
application number: M005
ANTIBACTERIAL HAND SANITIZERETHYL ALCOHOLASC Marketing Ltd.b42ebe64-0cad-2d26-e053-2a95a90af3dd2025-04-07WarningsExact identifier
application number: M005
Anti-Bacterial HAND SANITIZERETHYL ALCOHOLDISNEY DESTINATIONS,LLCae739bda-edf3-634b-e053-2a95a90a73852025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc9ae42862-f730-9d67-e053-2a95a90af9552025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc7e8f4517-c996-8797-e053-2991aa0a4f582025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.43ab2651-6e0a-3d48-e054-00144ff88e882025-04-07WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATETAGRID LLC32396be0-f74a-5483-e063-6294a90ab3ae2025-04-07WarningsExact identifier
application number: M005
Antifungal Treatment Liquid 25 undeclylenic AcidUNDECYLENIC ACIDSANSAR, LLC2ae0f300-154e-44c8-bcc3-b5c334e661ac2025-04-02WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
application number: M005
Tagrid Jock Itch Miconazole Nitrate 2%MICONAZOLE NITRATETAGRID LLC31abdc68-5027-15e7-e063-6394a90ac4e62025-03-31WarningsExact identifier
application number: M005
Tea Tree Oil Foot Soak and Body SoakZINC UNDECYLENATESANSAR, LLCc43816ac-2228-43ce-ba45-80cf3a7788f22025-03-28WarningsExact identifier
application number: M005
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsExact identifier
application number: M005
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
application number: M005
1236-CS Antifungal Powder (Talc Free)1236-CCANTIFUNGAL POWDER(TALC FREE)Dynarex Corporation312ba573-4008-83e6-e063-6294a90a4a6d2025-03-25WarningsExact identifier
application number: M005
Antifungal Medicated BarTOLNAFTATERoyceDerm LLC31305ed2-a0a0-6d4c-e063-6294a90a6ba52025-03-25WarningsExact identifier
application number: M005
Forticept Antimicrobial Hydrogel Wound DressingBENZETHONIUM CHLORIDE, THYMOLLidan, Inccd5b7a72-1b87-434d-973e-071d2c8a438c2025-03-25WarningsExact identifier
application number: M005
Forticept HP Antiseptic Wound CleanserBENZALKONIUM CHLORIDE, ALLANTOINLidan, inc.41bb46ee-edce-4e1b-bcfd-5c5729e1eb152025-03-25WarningsExact identifier
application number: M005
Forticept Antifungal Foot GelCLOTRIMAZOLELidan, Inc.1b5851fc-ae73-4e54-bb62-3ff928628b972025-03-25WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.14d2a661-a490-41ca-b84f-f2be3bc271b42025-03-24WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNcaba588a-13df-4035-ac41-6b4ec90cd88d7
309367clotrimazole 10 MG/ML Topical CreamSCDcaba588a-13df-4035-ac41-6b4ec90cd88d7
309367clotrimazole 1 % Topical CreamSYcaba588a-13df-4035-ac41-6b4ec90cd88d7
309367clotrimazole 1 % Topical CreamPSN0b32a369-ea1c-4cb8-8ea1-07bba8f16b724
309367clotrimazole 10 MG/ML Topical CreamSCD0b32a369-ea1c-4cb8-8ea1-07bba8f16b724
309367clotrimazole 1 % Topical CreamSY0b32a369-ea1c-4cb8-8ea1-07bba8f16b724
309367clotrimazole 1 % Topical CreamPSN7c64553b-589c-4e65-a6f0-b2847bbbe8a62
309367clotrimazole 10 MG/ML Topical CreamSCD7c64553b-589c-4e65-a6f0-b2847bbbe8a62
309367clotrimazole 1 % Topical CreamSY7c64553b-589c-4e65-a6f0-b2847bbbe8a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1272-11005361272111 TUBE in 1 CARTON (0536-1272-11) / 14 g in 1 TUBE1 tube2020-01-142027-01-31NoNoCurrent
0536-1272-22005361272221 TUBE in 1 CARTON (0536-1272-22) / 28 g in 1 TUBE1 tube2020-01-142027-03-31NoNoCurrent