Dermatin

Product NDC
54473-096
11-digit product format
544730096
Labeler code
54473
Product ID
54473-096_30cde80e-e74e-d8f5-e063-6394a90abd48
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
Substance
CLOTRIMAZOLE
Active strength
.01 g/g
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
Dermatin
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE.01 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367, 1112455

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-096-01DermatinAntifungal14 g in 1 TUBECREAM147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-096DERMATIN ANTIFUNGAL (CLOTRIMAZOLE) CREAM [MELALEUCA, INC.]7Current NDC, Legacy NDC, 1 package rows20250409_e993fa3b-1d85-46b7-bda5-ed875be74c4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455Dermatin Antifungal 1 % Topical CreamPSNe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455clotrimazole 10 MG/ML Topical Cream [Dermatin]SBDe993fa3b-1d85-46b7-bda5-ed875be74c4e7
309367clotrimazole 10 MG/ML Topical CreamSCDe993fa3b-1d85-46b7-bda5-ed875be74c4e7
309367clotrimazole 1 % Topical CreamSYe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455Dermatin 10 MG/ML Topical CreamSYe993fa3b-1d85-46b7-bda5-ed875be74c4e7
1112455Dermatin Antifungal 1 % Topical CreamSYe993fa3b-1d85-46b7-bda5-ed875be74c4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-096-015447300960114 g in 1 TUBE (54473-096-01) 14 g2018-01-010000-00-00NoNoCurrent