1MED Clotrimazole 1% Antifungal Cream

Product NDC: 73750-091
Requested package NDC: 73750-091-10
11-digit product format: 737500091
Labeler code: 73750
Product ID: 73750-091_d736edf7-a371-5c85-e053-2a95a90aa7df
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole 1% Antifungal Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: QYK BRANDS LLC
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-01-01
Marketing end: 0000-00-00
Substance: CLOTRIMAZOLE
Active strength: 1 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73750-091	73750-091-10	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73750-091-05	2023-07-28	C162847	48780-1	0191ceaa-6226-198a-e063-dbdaa90aec3e	HUMAN OTC DRUG LABEL
73750-091-10	2023-07-28	C162847	48780-1	0191ceaa-6226-198a-e063-dbdaa90aec3e	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73750-091-05	1MED Clotrimazole 1% Antifungal Cream	15 g in 1 TUBE	CREAM	15		2
73750-091-10	1MED Clotrimazole 1% Antifungal Cream	30 g in 1 TUBE	CREAM	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73750-091-05	GM - Gram	73750-091	ae11b1d7-e245-48ee-8b09-b0ebc5938c56	1	2022-06-06
73750-091-10	GM - Gram	73750-091	a296d895-ad5f-4b03-a5e8-95e10ecdea5b	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73750-091	1MED CLOTRIMAZOLE 1% ANTIFUNGAL CREAM (CLOTRIMAZOLE 1% ANTIFUNGAL CREAM) CREAM [QYK BRANDS LLC]	2	Legacy NDC, 2 package rows	20220205_d7183409-f6ff-4915-e053-2a95a90a0979.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309367	clotrimazole 1 % Topical Cream	PSN	d7183409-f6ff-4915-e053-2a95a90a0979	2
309367	clotrimazole 10 MG/ML Topical Cream	SCD	d7183409-f6ff-4915-e053-2a95a90a0979	2
309367	clotrimazole 1 % Topical Cream	SY	d7183409-f6ff-4915-e053-2a95a90a0979	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73750-091-10	73750009110	30 g in 1 TUBE (73750-091-10)	30 g	2022-01-01	0000-00-00	No	No	Current