Oxytrol for Women

Product NDC: 0023-9637
11-digit product format: 000239637
Labeler code: 0023
Product ID: 0023-9637_cc404430-2345-4294-8efc-e1e996cc17b2
Type: HUMAN OTC DRUG
Nonproprietary name: Oxybutynin
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Allergan, Inc.
Application: NDA202211
Marketing category: NDA
Marketing start: 2016-01-01
Substance: OXYBUTYNIN
Active strength: 3.9 mg/d
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N202211-001	OXYTROL FOR WOMEN	OXYBUTYNIN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2013-01-25

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N202211-001	6743441	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081249	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081250	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081251	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081252	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7179483	2020-04-26	U-1329		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202211-001	6743441	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081249	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081250	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081251	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081252	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7179483	2020-04-26	U-1329		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202211-001	6743441	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081249	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081250	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081251	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081252	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7179483	2020-04-26	U-1329		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202211-001	6743441	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081249	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081250	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081251	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081252	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7179483	2020-04-26	U-1329		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202211-001	6743441	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081249	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081250	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081251	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081252	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7179483	2020-04-26	U-1329		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202211-001	6743441	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081249	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081250	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081251	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081252	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7179483	2020-04-26	U-1329		`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxytrol for Women
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBUTYNIN	3.9 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K9P6MC7092	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403799	Internal RxNorm lookup
404448	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
8cdc5b4d-ff8d-4010-97d7-313422a0b868	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3544f362-07fc-93b1-457b-1fba00be087a	Product name	8	20230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4	Product name	8	20210525
982338c6-c45c-b6b4-1452-14b01fbdf98d	Product name	2	20180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6	Product name	2	20171212
3544f362-07fc-93b1-457b-1fba00be087a	Product name	2	20171212
8b00ae7e-01f2-f83c-632e-edfc23808364	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0023-9637-04	Oxytrol for Women	4 d in 1 PATCH	PATCH	4	7
0023-9637-04	Oxytrol for Women	16 in 1 CARTON	PATCH	16	7
0023-9637-08	Oxytrol for Women	32 in 1 CARTON	PATCH	32	7
0023-9637-08	Oxytrol for Women	4 d in 1 PATCH	PATCH	4	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-9637-04	EA - Each	0023-9637	37642404-e98d-40ac-a2c1-985cd0ee49af	1	2020-02-13
0023-9637-08	EA - Each	0023-9637	d665755a-2d3f-4a15-8e3c-978fafad4c84	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-9637	OXYTROL FOR WOMEN (OXYBUTYNIN) PATCH [ALLERGAN, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20250109_8cdc5b4d-ff8d-4010-97d7-313422a0b868.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxytrol for Women	OXYBUTYNIN	Allergan, Inc.	8cdc5b4d-ff8d-4010-97d7-313422a0b868	2024-08-15	Warnings	Exact identifier application applno (NDA): 202211 application number: NDA202211 ndc (product): 0023-9637

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K9P6MC7092	OXYBUTYNIN	5633-20-5	OXYBUTYNIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403799	oxyBUTYnin 3.9 MG/Day Twice Weekly Transdermal System	PSN	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
404448	OXYTROL 3.9 MG/Day Twice Weekly Transdermal System	PSN	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
404448	84 HR oxybutynin 0.162 MG/HR Transdermal System [Oxytrol]	SBD	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
403799	84 HR oxybutynin 0.162 MG/HR Transdermal System	SCD	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
404448	84 HR Oxytrol 0.162 MG/HR Transdermal System	SY	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
403799	oxybutynin 0.162 MG/HR 84 HR Transdermal Patch	SY	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
403799	oxybutynin 3.9 MG/Day Twice Weekly Transdermal Patch	SY	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
403799	oxybutynin 3.9 MG/Day Twice Weekly Transdermal System	SY	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
404448	Oxytrol 3.9 MG/Day Twice Weekly Transdermal Patch	SY	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7
404448	OXYTROL 3.9 MG/Day Twice Weekly Transdermal System	SY	8cdc5b4d-ff8d-4010-97d7-313422a0b868	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-9637-04	00023963704	16 PATCH in 1 CARTON (0023-9637-04) / 4 d in 1 PATCH	16 patch	2016-01-01	0000-00-00	No	No	Current
0023-9637-08	00023963708	32 PATCH in 1 CARTON (0023-9637-08) / 4 d in 1 PATCH	32 patch	2019-10-01	0000-00-00	No	No	Current