clotrimazole

Product NDC: 45802-434
11-digit product format: 458020434
Labeler code: 45802
Product ID: 45802-434_467f8f2f-09b1-4701-b796-57a10576f7ca
Type: HUMAN OTC DRUG
Nonproprietary name: Clotrimazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-06-03
Marketing end: 2027-04-30
Substance: CLOTRIMAZOLE
Active strength: 1 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Current FDA listing: Yes

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	45802-434	45802-434-01	D	Discontinued by firm		2026-10-15

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	1 g/100g

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
3dcd0158-ec51-4fa7-a26a-02c2926156c0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45802-434-01	clotrimazole	15 g in 1 TUBE	CREAM	15	8
45802-434-01	clotrimazole	1 in 1 CARTON	CREAM	1	8
45802-434-11	clotrimazole	1 in 1 CARTON	CREAM	1	8
45802-434-11	clotrimazole	28 g in 1 TUBE	CREAM	28	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-434-01	GM - Gram	45802-434	d14ca4ba-e10d-4e66-9753-635847aed1a6	1	2012-07-24
45802-434-11	GM - Gram	45802-434	a0b1e4f4-5f17-41be-ab4f-f972953bca2e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]	3
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-434	CLOTRIMAZOLE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]	7	Current NDC, Legacy NDC, 4 package rows	20240910_3dcd0158-ec51-4fa7-a26a-02c2926156c0.zip

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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnaftate	TOLNAFTATE	Sheffield Pharmaceuticals LLC	ca52af37-c3a2-414c-a24a-a37a92925133	2025-02-20	Warnings	Exact identifier application number: M005
Dr Sheffield Athletes Foot	CLOTRIMAZOLE	Sheffield Pharmaceuticals LLC	b8b8e6b2-1022-4592-91ba-3cf94c7cf318	2025-02-19	Warnings	Exact identifier application number: M005
UKVOA Toenail Fungus Treatment	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2e3cde7b-850e-f9d2-e063-6394a90adb18	2025-02-16	Warnings	Exact identifier application number: M005
UKOVA FOOT ODOR PROBIOTIC	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2de0225d-dd85-e2da-e063-6294a90a050b	2025-02-11	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes Foot Wipes	TOLNAFTATE	Cosco International, Inc.	cde656a9-7841-4a73-a2f4-f5a76a3e15c1	2025-02-06	Warnings	Exact identifier application number: M005
Silka Athletes Foot	MICONAZOLE NITRATE	Genomma Lab USA	307104a2-2df6-43b0-bf3f-f4d93d3e40f1	2025-02-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	fd7dd2eb-03a7-ef1f-e053-6294a90a8557	2025-02-04	Warnings	Exact identifier application number: M005
Molecular AF	TOLNAFTATE	Renu Laboratories, LLC	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	2025-02-03	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Papalo Group LLC	2d2c0e12-123d-75bd-e063-6394a90ae546	2025-01-31	Warnings	Exact identifier application number: M005
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	IDO PHARM	d5833c6f-81dd-6ff6-e053-2995a90ac76d	2025-01-30	Warnings	Exact identifier application number: M005
AWAS ALCOHOLSPRAY	ALCOHOL	IDO PHARM	03010837-0289-3e08-e063-6394a90a7d04	2025-01-30	Warnings	Exact identifier application number: M005
ELON Dual Defense Anti Fungal Formula	UNDECYLENIC ACID	Little Giant Holdings LLC	45c4567d-7876-6459-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M005
DCH Labs Antifungal Jock	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	fc749882-2e1e-cad3-e053-6294a90a33ca	2025-01-27	Warnings	Exact identifier application number: M005
Antifungal Pen	UNDECYLENIC ACID 25%	XF Agencija Limited	a15d4512-0fc6-424f-9dd3-ab433d9b7a26	2025-01-27	Warnings	Exact identifier application number: M005
Mata Hongos	UNDECYLENIC ACID	Vitamex USA, Corp	21ca7edb-dde3-5846-e063-6394a90a3cc0	2025-01-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	53cb4c0d-40b5-4cf3-b122-fd6dd654883f	2025-01-23	Warnings	Exact identifier application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Natureplex, LLC	575b8645-9166-4242-a74f-f4aa4acaaf3d	2025-01-15	Warnings	Exact identifier application number: M005
Tobcharm Antifungal Treatment Cream	ANTIFUNGAL TREATMENT CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba241cc-2767-1190-e063-6294a90ac66b	2025-01-13	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2%	MICONAZOLE NITRATE	Akron Pharma Inc.	8933f939-098a-4257-8d9c-4d5c3240e9a6	2025-01-10	Warnings	Exact identifier application number: M005
ANTI-ITCH FEMININE CARE	HYDROCORTISONE 0.5%	OL PHARMA TECH, LLC Drs PHARMACY	d6fa5ff3-ebdc-222d-e053-2a95a90a88d5	2025-01-09	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	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	14
309367	clotrimazole 10 MG/ML Topical Cream	SCD	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	14
309367	clotrimazole 1 % Topical Cream	SY	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	14
309367	clotrimazole 1 % Topical Cream	PSN	b63a3fe5-5684-41bc-ad6c-69c54e5b942d	10
309367	clotrimazole 10 MG/ML Topical Cream	SCD	b63a3fe5-5684-41bc-ad6c-69c54e5b942d	10
309367	clotrimazole 1 % Topical Cream	SY	b63a3fe5-5684-41bc-ad6c-69c54e5b942d	10
309367	clotrimazole 1 % Topical Cream	PSN	3dcd0158-ec51-4fa7-a26a-02c2926156c0	8
309367	clotrimazole 10 MG/ML Topical Cream	SCD	3dcd0158-ec51-4fa7-a26a-02c2926156c0	8
309367	clotrimazole 1 % Topical Cream	SY	3dcd0158-ec51-4fa7-a26a-02c2926156c0	8
309367	clotrimazole 1 % Topical Cream	PSN	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	7
309367	clotrimazole 10 MG/ML Topical Cream	SCD	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	7
309367	clotrimazole 1 % Topical Cream	SY	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	7
309367	clotrimazole 1 % Topical Cream	PSN	627375fb-2f20-16bc-e053-2a91aa0a1542	5
309367	clotrimazole 10 MG/ML Topical Cream	SCD	627375fb-2f20-16bc-e053-2a91aa0a1542	5
309367	clotrimazole 1 % Topical Cream	SY	627375fb-2f20-16bc-e053-2a91aa0a1542	5
309367	clotrimazole 1 % Topical Cream	PSN	54241254-1d9a-346a-e054-00144ff8d46c	4
309367	clotrimazole 10 MG/ML Topical Cream	SCD	54241254-1d9a-346a-e054-00144ff8d46c	4
309367	clotrimazole 1 % Topical Cream	SY	54241254-1d9a-346a-e054-00144ff8d46c	4
309367	clotrimazole 1 % Topical Cream	PSN	706f3bb5-1ada-420a-9d8e-79aea018df53	1
309368	clotrimazole 1 % Vaginal Cream	PSN	ef0b0fca-40c4-4bb6-8a0a-9c3ff717866f	1
309367	clotrimazole 10 MG/ML Topical Cream	SCD	706f3bb5-1ada-420a-9d8e-79aea018df53	1
309368	clotrimazole 10 MG/ML Vaginal Cream	SCD	ef0b0fca-40c4-4bb6-8a0a-9c3ff717866f	1
309367	clotrimazole 1 % Topical Cream	SY	706f3bb5-1ada-420a-9d8e-79aea018df53	1
309368	clotrimazole 1 % Vaginal Cream	SY	ef0b0fca-40c4-4bb6-8a0a-9c3ff717866f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-434-01	45802043401	1 TUBE in 1 CARTON (45802-434-01) > 15 g in 1 TUBE	1 tube	2011-06-03	0000-00-00	No	No	Current
45802-434-11	45802043411	1 TUBE in 1 CARTON (45802-434-11) / 28 g in 1 TUBE	1 tube	2011-06-09	2027-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole Cream USP, 1% Drug Facts	A-S Medication Solutions	2026-05-11	HUMAN OTC DRUG LABEL	14
Clotrimazole Cream USP, 1% Drug Facts	Padagis Israel Pharmaceuticals Ltd	2026-01-22	HUMAN OTC DRUG LABEL	8
Clotrimazole Cream USP, 1% Drug Facts	Bryant Ranch Prepack	2024-10-03	HUMAN OTC DRUG LABEL	3
Perrigo Clotrimazole Cream USP, 1% Drug Facts	NuCare Pharmaceuticals, Inc.	2024-07-17	HUMAN OTC DRUG LABEL	4
Perrigo Clotrimazole Cream USP, 1% Drug Facts	A-S Medication Solutions	2024-06-20	HUMAN OTC DRUG LABEL	10
Perrigo Clotrimazole Cream USP, 1% Drug Facts	NuCare Pharmaceuticals,Inc.	2024-06-06	HUMAN OTC DRUG LABEL	5
Perrigo Clotrimazole Cream USP, 1% Drug Facts	Preferred Pharmaceuticals Inc.	2024-04-05	HUMAN OTC DRUG LABEL	8
Perrigo Clotrimazole Cream USP, 1% Drug Facts	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	7
Clotrimazole Vaginal Cream	Central Texas Community Health Centers	2016-11-16	HUMAN OTC DRUG LABEL	1
Perrigo Clotrimazole Cream USP, 1% Drug Facts	Rebel Distributors Corp	2011-12-27	HUMAN OTC DRUG LABEL	1