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

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 Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

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

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