FDA.reportPublic FDA data

RUGBY ANTIFUNGAL CLOTRIMAZOLE

Product NDC
68788-8091
11-digit product format
687888091
Labeler code
68788
Product ID
68788-8091_979c1522-30e8-4e67-b0ef-c3f52215c4c7
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
333C
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-05
Marketing end
2027-01-30
Substance
CLOTRIMAZOLE
Active strength
.01 g/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

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
caba588a-13df-4035-ac41-6b4ec90cd88dAvailable 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
68788-8091-2RUGBY ANTIFUNGAL CLOTRIMAZOLE28 g in 1 TUBECREAM287
68788-8091-2RUGBY ANTIFUNGAL CLOTRIMAZOLE1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8091RUGBY ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20250309_caba588a-13df-4035-ac41-6b4ec90cd88d.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEPreferred Pharmaceuticals Inc.caba588a-13df-4035-ac41-6b4ec90cd88d2026-04-01WarningsExact identifier
ndc (product): 68788-8091

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8091-2687888091021 TUBE in 1 CARTON (68788-8091-2) / 28 g in 1 TUBE1 tube2021-10-052027-01-30NoNoCurrent