RUGBY ANTIFUNGAL CLOTRIMAZOLE

Product NDC: 0536-1272
11-digit product format: 005361272
Labeler code: 0536
Product ID: 0536-1272_2a90048a-67fe-47ae-ab8b-db872b5e1fda
Type: HUMAN OTC DRUG
Nonproprietary name: CLOTRIMAZOLE
Dosage form: CREAM
Route: TOPICAL
Labeler: Rugby Laboratories
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-14
Marketing end: 2027-03-31
Substance: CLOTRIMAZOLE
Active strength: .01 g/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
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
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0536-1272		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-1272	0536-1272-22	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-1272	0536-1272-11	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: RUGBY ANTIFUNGAL CLOTRIMAZOLE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	.01 g/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
0b32a369-ea1c-4cb8-8ea1-07bba8f16b72	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
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
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
0536-1272-11	RUGBY ANTIFUNGAL CLOTRIMAZOLE	1 in 1 CARTON	CREAM	1	4
0536-1272-11	RUGBY ANTIFUNGAL CLOTRIMAZOLE	14 g in 1 TUBE	CREAM	14	4
0536-1272-22	RUGBY ANTIFUNGAL CLOTRIMAZOLE	1 in 1 CARTON	CREAM	1	4
0536-1272-22	RUGBY ANTIFUNGAL CLOTRIMAZOLE	28 g in 1 TUBE	CREAM	28	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-1272	RUGBY ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [RUGBY]	3	Current NDC, Legacy NDC, 4 package rows	20250117_0b32a369-ea1c-4cb8-8ea1-07bba8f16b72.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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUNGAL NAIL TREATMENT kit .liquid.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c93390-ee07-4f78-e063-6394a90add42	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .cream.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c9d9fa-09ad-e26a-e063-6394a90a0ed9	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56cb7085-87d8-4273-e063-6394a90ac5df	2026-07-17	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL FOOT CARE	TOLNAFTATE 1% ANTIFUNGAL FOOT CARE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b10492-894c-33e1-e063-6394a90a8c0f	2026-07-17	Warnings	Exact identifier application number: M005
Foot Choice-Nail Fungal Pen	UNDECYLENIC ACID	Foot Choice LLC	4b0036a6-8751-4f44-b6b1-5be57fa92cdc	2026-07-17	Warnings	Exact identifier application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream	2% MICONAZOLE NITRATE ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56b54359-db21-b8b4-e063-6394a90a6f8c	2026-07-16	Warnings	Exact identifier application number: M005
DRAVYNOR BALANITIS RELIEF Cream	MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b76a52-0743-4fe6-e063-6294a90a98a8	2026-07-16	Warnings	Exact identifier application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream	5% BENZOYL PEROXIDE FOLLICULITIS CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56c558fa-303f-fc52-e063-6394a90a72f0	2026-07-16	Warnings	Exact identifier application number: M005
Antifungal Ringworm Treatment Cream	MICONAZOLE NITRATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a2ceea-c4c0-c30c-e063-6394a90a0e6a	2026-07-15	Warnings	Exact identifier application number: M005
Medi-First Antifungal Cream Miconazole Cream	MICONAZOLE	Unifirst First Aid Corporation	56a51b75-9c23-bcd2-e063-6394a90a9b12	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Tinea Treatment	CLEAR ROOT LABS TINEA TREATMENT	Aidance Scientic Inc., DBA Aidance Skincare & Topicals	56a67bad-c677-d3b7-e063-6394a90ad205	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Antifungal Treatment	CLEAR ROOT LABS ANTIFUNGAL TREATMENT	Aidance Scientific, Inc., DBA Aidance Skincare & Topicals	5696bf23-230a-5f37-e063-6294a90a7413	2026-07-15	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL NAIL Liquid	TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID	Jiangxi Yudexi Pharmaceutical Co., LTD	56b17e50-bff1-5eb0-e063-6294a90a3c08	2026-07-15	Warnings	Exact identifier application number: M005
terrasil Antifungal Cleansing Bar	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	10a4fde0-87e1-4474-bcb5-255b0a7f1ecb	2026-07-14	Warnings	Exact identifier application number: M005
OAKDOLCHE Tea Tree Oil Antifungal	TOLNAFTATE	Nanjing Qiaotun Technology Co., Ltd.	569dee15-e68d-220e-e063-6294a90af7c5	2026-07-14	Warnings	Exact identifier application number: M005
Kimtara Nail Fungus Treatment	KIMTARA NAIL FUNGUS TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5678e260-10c4-f203-e063-6294a90a6223	2026-07-13	Warnings	Exact identifier application number: M005
Aiilo NAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Guangzhou Huixue Biotechnology Co., Ltd.	5689ac31-4d23-0fcc-e063-6394a90ac75b	2026-07-13		Exact identifier application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56519b25-f3c8-bcac-e063-6394a90af879	2026-07-11	Warnings	Exact identifier application number: M005
Joymeey FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5652a22e-7b43-3c31-e063-6294a90ae4f1	2026-07-11	Warnings	Exact identifier application number: M005
iBeaLee Nail Repair Pen	IBEALEE NAIL REPAIR PEN	Shenzhen Earth Surface Trading Co., Ltd.	564dc711-7fe2-7a8d-e063-6294a90aac26	2026-07-10	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	caba588a-13df-4035-ac41-6b4ec90cd88d	7
309367	clotrimazole 10 MG/ML Topical Cream	SCD	caba588a-13df-4035-ac41-6b4ec90cd88d	7
309367	clotrimazole 1 % Topical Cream	SY	caba588a-13df-4035-ac41-6b4ec90cd88d	7
309367	clotrimazole 1 % Topical Cream	PSN	0b32a369-ea1c-4cb8-8ea1-07bba8f16b72	4
309367	clotrimazole 10 MG/ML Topical Cream	SCD	0b32a369-ea1c-4cb8-8ea1-07bba8f16b72	4
309367	clotrimazole 1 % Topical Cream	SY	0b32a369-ea1c-4cb8-8ea1-07bba8f16b72	4
309367	clotrimazole 1 % Topical Cream	PSN	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2
309367	clotrimazole 10 MG/ML Topical Cream	SCD	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2
309367	clotrimazole 1 % Topical Cream	SY	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1272-11	00536127211	1 TUBE in 1 CARTON (0536-1272-11) / 14 g in 1 TUBE	1 tube	2020-01-14	2027-01-31	No	No	Current
0536-1272-22	00536127222	1 TUBE in 1 CARTON (0536-1272-22) / 28 g in 1 TUBE	1 tube	2020-01-14	2027-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RUGBY ® ANTIFUNGAL CREAM CLOTRIMAZOLE 1%	Preferred Pharmaceuticals Inc.	2026-04-01	HUMAN OTC DRUG LABEL	7
RUGBY ® ANTIFUNGAL CREAM CLOTRIMAZOLE 1%	Rugby Laboratories	2025-09-16	HUMAN OTC DRUG LABEL	4
RUGBY ® ANTIFUNGAL CREAM CLOTRIMAZOLE 1%	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	2