Equaline Tioconazole 1

Product NDC: 41163-032
Requested package NDC: 41163-032-54
11-digit product format: 411630032
Labeler code: 41163
Product ID: 41163-032_e99c3066-a16d-4940-9001-2d83b77f7176
Type: HUMAN OTC DRUG
Nonproprietary name: Tioconazole
Dosage form: OINTMENT
Route: VAGINAL
Labeler: Supervalu Inc
Application: ANDA075915
Marketing category: ANDA
Marketing start: 2016-03-08
Marketing end: 0000-00-00
Substance: TIOCONAZOLE
Active strength: 7 g/100g
NDC exclude flag: No
Listing certified through: 2020-12-31
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	41163-032	41163-032-54	D	Discontinued by firm		2026-11-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075915-001	TIOCONAZOLE	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL			2001-11-21

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075915-001	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL	2001-11-21	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41163-032-54	Equaline Tioconazole 1	1 in 1 POUCH	OINTMENT	1		3
41163-032-54	Equaline Tioconazole 1	1 in 1 CARTON	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-032	EQUALINE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [UNITED NATURAL FOODS, INC. DBA UNFI]	3	Legacy NDC, 2 package rows	20230826_e5bfbe25-9f90-41ff-b15a-9f9389de7052.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MONISTAT TIOCONAZOLE 1	TIOCONAZOLE	Insight Pharmaceuticals LLC	587e42b4-cbdc-4a03-afae-f9e5e6605937	2026-09-04	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
dg health tioconazole 1	TIOCONAZOLE	Dolgencorp Inc	39bada3c-510e-47ae-a125-30e41e483382	2026-08-19	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Up and up tioconazole 1	TIOCONAZOLE	Target Corporation	4086b77c-b08d-4f53-a4ab-4f5af814a605	2026-08-11	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
TIOCONAZOLE 1	TIOCONAZOLE	Amazon.com Services LLC	cea5dd1c-a59a-4877-8476-85ed6cc4e221	2026-07-29	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
TIOCONAZOLE 1	TIOCONAZOLE	Safeway	5b7d477e-835b-4557-9a05-c5959dbc803e	2026-05-01	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Tioconazole 1	TIOCONAZOLE	H E B	8bd3f5e8-5a8f-4d6a-b257-c315eec66318	2026-04-04	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
tioconazole 1	TIOCONAZOLE	Meijer Distribution Inc	7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a31	2026-03-26	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Equate tioconazole 1 day	TIOCONAZOLE	Wal-Mart Stores Inc	6b3ee10a-d945-41f4-bbb5-ff2e2fdcd22c	2025-08-11	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
signature care tioconazole 1	TIOCONAZOLE	Safeway	22ac4774-87b4-437f-8520-e4a4ed6e1c55	2025-03-20	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Leader Tioconazole 1	TIOCONAZOLE	Cardinal Health 110, LLC. dba Leader	6db31d83-acd7-4e4e-8f98-fe46102a6832	2025-02-19	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
CareOne Tioconazole 1	TIOCONAZOLE	American Sales Company	78139c20-6258-4da6-abd3-9ba5e5899fd9	2024-12-18	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Tioconazole 1	TIOCONAZOLE	Walgreen Company	c05a4413-8a5f-4b91-9c22-b1db785e8e9e	2024-12-18	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
basic care tioconazole	TIOCONAZOLE	Amazon.com Services LLC	0484dbe9-37a6-4b98-b29a-3c006205c94d	2024-12-18	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
tioconazole 1	TIOCONAZOLE	CVS Pharmacy	49ef74a9-9850-4427-8658-ee4dd9050ae0	2024-08-09	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Topcare Tioconazole 1	TIOCONAZOLE	Topco Associates LLC	fce06160-2098-4ac1-9cc3-a584d4f5a51d	2024-08-08	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
VAGISTAT	TIOCONAZOLE	Combe Incorporated	da8eaa33-4195-487f-a234-472dd1036225	2024-06-22	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
good sense tioconazole 1	TIOCONAZOLE	L. Perrigo Company	d39ac447-6e1d-4b77-90c1-a9a653661f42	2023-12-19	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
foster and thrive tioconazole	TIOCONAZOLE	Strategic Sourcing Services LLC	daa1027d-de49-41dc-9d4d-9bbdd7b359c8	2023-10-25	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915
Equaline Tioconazole 1	TIOCONAZOLE	United Natural Foods, Inc. dba UNFI	e5bfbe25-9f90-41ff-b15a-9f9389de7052	2023-07-24	Warnings	Exact identifier application applno (ANDA): 075915 application number: ANDA075915 ndc (package): 41163-032-54 ndc (product): 41163-032 ndc11 (package): 41163003254

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S57Y5X1117	TIOCONAZOLE	65899-73-2	TIOCONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198380	tioconazole 6.5 % Vaginal Ointment	PSN	e5bfbe25-9f90-41ff-b15a-9f9389de7052	3
198380	tioconazole 0.065 MG/MG Vaginal Ointment	SCD	e5bfbe25-9f90-41ff-b15a-9f9389de7052	3
198380	tioconazole 6.5 % Vaginal Ointment	SY	e5bfbe25-9f90-41ff-b15a-9f9389de7052	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-032-54	41163003254	1 POUCH in 1 CARTON (41163-032-54) > 1 APPLICATOR in 1 POUCH > 4.6 g in 1 APPLICATOR	1 pouch	2016-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SuperValu Inc. Tioconazole-1 Drug Facts	United Natural Foods, Inc. dba UNFI	2023-07-24	HUMAN OTC DRUG LABEL	3