Clotrimazole Cream 1%

Product NDC: 79503-105
11-digit product format: 795030105
Labeler code: 79503
Product ID: 79503-105_cd195cd1-9d5d-47aa-b2ea-40963eb3045e
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Ezricare Llc
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-08-19
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	79503-105		D	Discontinued by firm		2026-10-12
excluded package	package	79503-105	79503-105-30	D	Discontinued by firm		2026-10-12

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79503-105-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79503-105-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79503-105-30	GM - Gram	79503-105	66b69b89-4095-4f57-9011-f42b62b9942e	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79503-105	CLOTRIMAZOLE CREAM 1% (CLOTRIMAZOLE) CREAM [EZRICARE LLC]	3	Legacy NDC	20240112_e11ddb7d-a921-429c-b3ee-5e5e8f56c7ad.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79503-105-30	79503010530	1 TUBE in 1 CARTON (79503-105-30) > 30 g in 1 TUBE	1 tube	2021-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EZRI CARE TM Clotrimazole Cream USP 1%	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN OTC DRUG LABEL	2
EZRI CARE TM Clotrimazole Cream USP 1%	Ezricare Llc	2024-01-11	HUMAN OTC DRUG LABEL	3