Clotrimazole Topical Solution USP, 1%

Product NDC: 50228-502
Requested package NDC: 50228-502-30
11-digit product format: 502280502
Labeler code: 50228
Product ID: 50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clotrimazole Topical Solution USP, 1%
Dosage form: SOLUTION
Route: TOPICAL
Labeler: ScieGen Pharmaceuticals, Inc
Application: ANDA216569
Marketing category: ANDA
Marketing start: 2023-10-16
Substance: CLOTRIMAZOLE
Active strength: 10 mg/mL
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216569-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT		2023-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216569-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216569-001	CLOTRIMAZOLE	1%	SOLUTION / TOPICAL	AT	2023-10-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216569-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216569-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216569-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216569-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216569-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216569-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216569-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216569-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216569-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216569-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216569-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216569-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216569-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216569-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216569-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216569-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216569-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216569-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216569-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216569-001	AT	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216569-001	AT	1	`a50c72e98297…`

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 Topical Solution USP, 1%
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOTRIMAZOLE	10 mg/mL

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
309370	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
15368c2a-572f-41fb-a3a1-7b1eb842faa8	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
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
50228-502-08	Clotrimazole Topical Solution USP, 1%	10 mL in 1 BOTTLE	SOLUTION	10	6
50228-502-08	Clotrimazole Topical Solution USP, 1%	1 in 1 CARTON	SOLUTION	1	6
50228-502-30	Clotrimazole Topical Solution USP, 1%	1 in 1 CARTON	SOLUTION	1	6
50228-502-30	Clotrimazole Topical Solution USP, 1%	30 mL in 1 BOTTLE	SOLUTION	30	6
50228-502-31	Clotrimazole Topical Solution USP, 1%	30 mL in 1 BOTTLE	SOLUTION	30	6
50228-502-31	Clotrimazole Topical Solution USP, 1%	1 in 1 CARTON	SOLUTION	1	6
50228-502-61	Clotrimazole Topical Solution USP, 1%	2 in 1 CARTON	SOLUTION	2	6
50228-502-61	Clotrimazole Topical Solution USP, 1%	30 mL in 1 BOTTLE	SOLUTION	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-502-08	ML - Milliliter	50228-502	b81e87d2-f240-43e6-9f5f-1207bfba4d4a	1	2024-06-10
50228-502-30	ML - Milliliter	50228-502	f65304c3-7695-49c5-b5b4-7b276de0a0a3	1	2024-06-10
50228-502-61	ML - Milliliter	50228-502	2bd8b18c-1ea6-4509-b677-e222465a7916	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-502	CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% SOLUTION [SCIEGEN PHARMACEUTICALS, INC]	4	Current NDC, 8 package rows	20240312_15368c2a-572f-41fb-a3a1-7b1eb842faa8.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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole Topical Solution USP, 1%	CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%	ScieGen Pharmaceuticals, Inc	15368c2a-572f-41fb-a3a1-7b1eb842faa8	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216569 application number: ANDA216569 ndc (package): 50228-502-30 ndc (product): 50228-502 ndc11 (package): 50228050230
Clotrimazole Topical Solution USP, 1%	CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%	Allegis Holdings, LLC	529bb597-b291-42fb-b45f-744a55df64f1	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216569 application number: ANDA216569
CLOTRIMAZOLE	CLOTRIMAZOLE	AARNA USA INC	4bd825f4-f5e2-aab7-e063-6394a90ad6a4	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216569 application number: ANDA216569
Clotrimazole Topical Solution USP, 1%	CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%	Akron Pharma Inc.	32b968ce-e112-441c-a91f-c62f2f67b57c	2024-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216569 application number: ANDA216569

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
309370	clotrimazole 1 % Topical Solution	PSN	15368c2a-572f-41fb-a3a1-7b1eb842faa8	6
309370	clotrimazole 10 MG/ML Topical Solution	SCD	15368c2a-572f-41fb-a3a1-7b1eb842faa8	6
309370	clotrimazole 1 % Topical Solution	SY	15368c2a-572f-41fb-a3a1-7b1eb842faa8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50228-502-30	50228050230	1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE	1 bottle	2023-10-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clotrimazole Topical Solution, USP 1%	ScieGen Pharmaceuticals, Inc \| Saptalis Pharmaceuticals LLC \| ScieGen Pharmaceuticals, Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	6