CLOTRIMAZOLE 1%

Product NDC: 87228-1010
11-digit product format: 872281010
Labeler code: 87228
Product ID: 87228-1010_4a5bbe68-ad72-23b5-e063-6394a90a73e9
Type: HUMAN OTC DRUG
Nonproprietary name: clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: PHARMACY CHOICE INC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-11-14
Substance: CLOTRIMAZOLE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	87228-1010		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	87228-1010	87228-1010-5	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	87228-1010	87228-1010-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CLOTRIMAZOLE 1%
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G07GZ97H65	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309367	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43852cfb-6d28-e54f-e063-6394a90aa090	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
87228-1010-1	CLOTRIMAZOLE 1%	28.4 g in 1 TUBE	CREAM	28.4		3
87228-1010-5	CLOTRIMAZOLE 1%	5 in 1 CARTON	CREAM	5		3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WISH HAND SANITIZER Strawberry Musk	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	59143edb-41fe-0a1f-e063-6394a90a81a5	2026-08-15	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Rose Woods	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	58fb4491-2918-c486-e063-6394a90a621f	2026-08-14	Warnings	Exact identifier application number: M005
VXGXO antifungal with tea tree oil	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	58fd67c5-c985-13a7-e063-6294a90a40fb	2026-08-14	Warnings	Exact identifier application number: M005
Charmpoo ANTIFUNGAL BODY Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58ff4779-83a7-afe2-e063-6294a90a9f9a	2026-08-14	Warnings	Exact identifier application number: M005
TEATREEOILANTIFUNGAL	UNDECYLENIC ACID AND ZINC UNDECYLENATE	Foshan Chancheng District Xuntou Electronic Commerce Co., Ltd	5900904f-cf51-4398-e063-6394a90aca6c	2026-08-14	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	58f1707a-579b-1e06-e063-6294a90a5a9f	2026-08-13	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Mango Coconut Cream	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	58faa781-520b-92fa-e063-6294a90a9ecf	2026-08-13	Warnings	Exact identifier application number: M005
Gemachlich Zu Hause Vaginal Antifungal Gel	MICONAZOLE NITRATE	Guangzhou Xinhongda Trading Service Co., Ltd.	563cfb57-f10c-96a6-e063-6294a90a2b93	2026-08-12	Warnings	Exact identifier application number: M005
Hecila ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58c117cc-e039-86f6-e063-6394a90af18f	2026-08-12	Warnings	Exact identifier application number: M005
TOTCLEAR NAIL RENEWAL	UNDECYLENIC ACID	GOOD BRIDGE LLC	93605e22-920d-43c3-bb2b-6e3116a19f5e	2026-08-12	Warnings	Exact identifier application number: M005
TOTCLEAR NAIL RENEWAL	UNDECYLENIC ACID	GOOD BRIDGE LLC	fde7d6ea-1b44-4a88-820a-0f2e033727e1	2026-08-11	Warnings	Exact identifier application number: M005
XBOFPEN MULTI-PURPOSE TREATMENT	TOLNAFTATE 1% MULTI-PURPOSE TREATMENT	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58c2f50c-9c9e-4989-e063-6394a90abb21	2026-08-11	Warnings	Exact identifier application number: M005
RoyceDerm Athletes foot antifungal .cream.	MICONAZOLE NITRATE 2%	RoyceDerm LLC	58d23aa0-497e-4ece-e063-6294a90aef66	2026-08-11	Warnings	Exact identifier application number: M005
QualiLife persimmon foot and shoe	UNDECYLENIC ACID	Guangdong Aimu Biological Technology Co., Ltd	584966c7-ceae-91af-e063-6294a90ac1eb	2026-08-10	Warnings	Exact identifier application number: M005
Persiancat ANTIFUNGAL PEN	UNDECYLENIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	58affb96-6cfc-b1fb-e063-6294a90a340c	2026-08-10	Warnings	Exact identifier application number: M005
Dryello Tolnaftate 1% Antifungal	TOLNAFTATE	ProPedix, Inc.	58b6820c-f601-5921-e063-6294a90aa5e9	2026-08-10	Warnings	Exact identifier application number: M005
Medline	MICONAZOLE NITRATE	Medline Industries, LP	3c43ef91-bbd2-5e58-e063-6294a90a00d3	2026-08-05	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Family Dollar Services, Inc	57c20748-fdad-b73b-e063-6294a90a1c17	2026-08-04	Warnings	Exact identifier application number: M005
Lyssera Fungal Nail Renewal	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5843c1a0-ab60-bd64-e063-6294a90af858	2026-08-04	Warnings	Exact identifier application number: M005
YAMANGU FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5843cc12-de66-ca47-e063-6294a90ae55b	2026-08-04	Warnings	Exact identifier application number: M005

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	43852cfb-6d28-e54f-e063-6394a90aa090	3
309367	clotrimazole 10 MG/ML Topical Cream	SCD	43852cfb-6d28-e54f-e063-6394a90aa090	3
309367	clotrimazole 1 % Topical Cream	SY	43852cfb-6d28-e54f-e063-6394a90aa090	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87228-1010-1	87228101001	28.4 g in 1 TUBE (87228-1010-1)	28.4 g	2025-11-14	No	No	Current
87228-1010-5	87228101005	5 TUBE in 1 CARTON (87228-1010-5) / 28.4 g in 1 TUBE (87228-1010-1)	5 tube	2025-11-14	No	No	Current