ElixirCurozole

Product NDC
84546-0003
11-digit product format
845460003
Labeler code
84546
Product ID
84546-0003_46da2930-c495-ef32-e063-6394a90a99ee
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
ELIXIR HEALTHCARE USA, LLC.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-15
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
ElixirCurozole
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
84546-0003-1ElixirCurozole28.3 g in 1 TUBECREAM28.31
84546-0003-1ElixirCurozole1 in 1 BOXCREAM11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN0c468a9e-d092-4704-b742-92ecd99182091
309367clotrimazole 10 MG/ML Topical CreamSCD0c468a9e-d092-4704-b742-92ecd99182091
309367clotrimazole 1 % Topical CreamSY0c468a9e-d092-4704-b742-92ecd99182091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84546-0003-1845460003011 TUBE in 1 BOX (84546-0003-1) / 28.3 g in 1 TUBE1 tube2025-12-15NoNoHistorical