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 41 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatin AntifungalCLOTRIMAZOLEMelaleuca, Inc.e993fa3b-1d85-46b7-bda5-ed875be74c4e2025-03-20WarningsExact identifier
application number: M005
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsExact identifier
application number: M005
Forticept Antifungal Foot CreamCLOTRIMAZOLELidan, Inc.17abeb4d-b211-4b8c-a9d2-4c7baba2450c2025-03-07WarningsExact identifier
application number: M005
Terramed Just Think Comfort Antifungal Medicated Body WipesTOLNAFTATERida LLC34577389-8e5d-49ab-a208-9c87b6f3cec42025-03-06WarningsExact identifier
application number: M005
Athletes FootMICONAZOLE NITRATERida LLC85e98ef8-75c3-4be1-b59f-40b5312e21372025-03-06WarningsExact identifier
application number: M005
SOUTH BEACH MULTI-PURPOSE NAIL REPAIRUNDECYLENIC ACIDSOUTH BEACH HAIR CARE PROFESIONAL INC2fb0110c-b275-2a17-e063-6394a90a2d302025-03-06WarningsExact identifier
application number: M005
DG Health Athletes FootCLOTRIMAZOLEDolgencorp, Inc.20370b32-21ad-4362-9b46-c6149c9072312025-02-28WarningsExact identifier
application number: M005
Family Wellness Clotrimazole 1 Anti Fungal CreamCLOTRIMAZOLEFamily Dollar Stores, Inc0667dd81-5633-494e-857e-45fa276fe72c2025-02-25WarningsExact identifier
application number: M005
Family Wellness Athletes Foot Tolnaftate 1 CreamTOLNAFTATEFamily Dollar Stores, Incf72b5bcd-8834-4da9-aa74-78992ec2838f2025-02-25WarningsExact identifier
application number: M005
ANTIFUNGAL MEDICATED BODY WASHTOLNAFTATERida LLCe3ebce6f-88ca-4100-ac79-d300f44e48912025-02-25WarningsExact identifier
application number: M005
FUNGINIX AFTOLNAFTATEThe Sisquoc Healthcare Corporationf6cf5315-6678-486c-85b2-d4b3f748600e2025-02-25WarningsExact identifier
application number: M005
FUNGINIX JOCK ITCH TREATMENTTOLNAFTATEThe Sisquoc Healthcare Corporationb2ce1c25-93d5-441f-9b3b-68ae46400c2c2025-02-25WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsbf131f33-3ab2-4f43-add5-920e78ac36a72025-02-24WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.0052992a-819c-4c55-bd88-201a09a3573a2025-02-21WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes Foot WipesTOLNAFTATECosco International, Inc.cde656a9-7841-4a73-a2f4-f5a76a3e15c12025-02-06WarningsExact identifier
application number: M005
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact 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