Oxytrol for Women

Manufacturer
Allergan, Inc.
Effective date
2024-08-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:51:13

Label at a glance#

ProductOxytrol for Women
Active ingredientOXYBUTYNIN
Label structure9 sections

Dosage and administration

women 18 years of age and older: How to use the patch: open 1 pouch and apply patch immediately to a clean, dry and smooth area of skin on your abdomen, hips or buttocks. Do not put the patch on oily, damaged (cut or scraped), or irritated (rashes) skin. Do not put the patch on skin with oils, lotions or powders because that could keep the patch from sticking to your skin. wear patch under clothing, do not expose ...

Label contents#

Full prescribing information#

Active ingredient (in each patch [transdermal system])

OTC - ACTIVE INGREDIENT SECTION

Oxybutynin 3.9 mg/day

Purpose

OTC - PURPOSE SECTION

Overactive bladder treatment

Use

INDICATIONS & USAGE SECTION

  • treats overactive bladder in women
  • you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months:
    ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours)
    ○ urinary urgency (a strong need to urinate right away) 
    ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate)
  • non-drug therapies may also help you (see the consumer information leaflet inside the package)

Warnings

WARNINGS SECTION

For external use only

Frequent urination can also be caused by:

  • urinary tract infections (UTI)
  • diabetes
  • early pregnancy
  • other more serious conditions

If you think you might have one of these conditions, it is important to see your doctor before use.

Sleepiness, dizziness, confusion, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you.

Do not use if you

OTC - DO NOT USE SECTION

  • have any of these symptoms, which could be the sign of a UTI or other serious condition.
    See your doctor as soon as possible if you have:
    ○
    pain or burning when urinating. These symptoms may also be accompanied by a fever or chills.
    ○
    blood in your urine
    ○
    unexplained lower back or side pain
    ○
    urine that is cloudy, or foul-smelling
    ○
    are male. Your symptoms may be due to a more serious condition.
    ○
    are under the age of 18. It is not known if it works or is safe in children.
    ○
    only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence. This product will not work for that condition.
    ○
    have been told by a doctor you have urinary retention (are not able to empty your bladder)
    ○
    have been told by a doctor you have gastric retention (your stomach empties slowly after a meal)
    ○
    have glaucoma
    ○
    are allergic to oxybutynin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • symptoms of diabetes, such as:
    ○ excessive thirst
    ○ extreme hunger
  • unexplained weight loss
  • liver or kidney disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription medication for overactive bladder
  • taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision
  • taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example, ketoconazole, itraconazole)

When using this product

OTC - WHEN USING SECTION

  • you may have itching, rash or redness where the patch was placed
  • drinking alcohol may increase sleepiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you are not able to empty your bladder (urinary retention)
  • condition worsens, or if new symptoms appear
  • condition does not improve after 2 weeks of use
  • you have an allergic reaction to this product
  • you have severe redness, itchiness or blistering at the site of application

If pregnant or breastfeeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

women 18 years of age and older:

How to use the patch:

  • open 1 pouch and apply patch immediately to a clean, dry and smooth area of skin on your abdomen, hips or buttocks. Do not put the patch on oily, damaged (cut or scraped), or irritated (rashes) skin. Do not put the patch on skin with oils, lotions or powders because that could keep the patch from sticking to your skin.
  • wear patch under clothing, do not expose the patch to sunlight
  • do not cut the patch into smaller pieces
  • wear only 1 patch at a time for 4 days in a row
  • after 4 days, remove the used patch and apply a new one
  • change the patch every 4 days for as long as you use this product
  • each time you put on a new patch, change the place where you put it (i.e., abdomen, hips or buttocks)
  • if a patch falls off and you cannot press it back onto your skin, use a new patch

How to dispose of a used patch:

  • when you take off a used patch, fold it in half with the sticky sides together
  • throw it away so that it cannot be worn or swallowed by another person, especially a child, or a pet

Other information

OTHER SAFETY INFORMATION

  • product comes in individual sealed pouches, do not use if pouch is torn or opened
  • store between 20° to 25°C (68° to 77°F)
  • protect from moisture and humidity
  • do not store outside the sealed pouch

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylic adhesive, polyester/ethylene-vinyl acetate film, siliconized polyester film, and triacetin

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free: 1-888-OXYTROL (1-888-699-8765) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

© 2024 AbbVie. All rights reserved.

Made in USA

Distributed by: AbbVie Inc., North Chicago, IL 60064

OXYTROL and its design are trademarks of Allergan Sales, LLC, an AbbVie company.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-9637-04
Full Prescription Strength
OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day
Overactive Bladder Treatment
Oxytrol ® FOR WOMEN
RELIEF FROM
Overactive Bladder
1 Patch Treats for
4 Days/4 Nights

4 PATCHES
(Transdermal Systems )
16-Day Supply

PRINCIPAL DISPLAY PANEL NDC 0023-9637-04 Full Prescription Strength OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day Overactive Bladder Treatment Oxytrol® FOR WOMEN RELIEF FROM Overacti...PRINCIPAL DISPLAY PANEL NDC 0023-9637-04 Full Prescription Strength OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day Overactive Bladder Treatment Oxytrol® FOR WOMEN RELIEF FROM Overacti...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
403799oxyBUTYnin 3.9 MG/Day Twice Weekly Transdermal SystemPSN7
404448OXYTROL 3.9 MG/Day Twice Weekly Transdermal SystemPSN7
40444884 HR oxybutynin 0.162 MG/HR Transdermal System [Oxytrol]SBD7
40379984 HR oxybutynin 0.162 MG/HR Transdermal SystemSCD7
40444884 HR Oxytrol 0.162 MG/HR Transdermal SystemSY7
403799oxybutynin 0.162 MG/HR 84 HR Transdermal PatchSY7
403799oxybutynin 3.9 MG/Day Twice Weekly Transdermal PatchSY7
403799oxybutynin 3.9 MG/Day Twice Weekly Transdermal SystemSY7
404448Oxytrol 3.9 MG/Day Twice Weekly Transdermal PatchSY7
404448OXYTROL 3.9 MG/Day Twice Weekly Transdermal SystemSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYBUTYNIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-9637-04Oxytrol for Women4 d in 1 PATCHPATCH47
0023-9637-04Oxytrol for Women16 in 1 CARTONPATCH167
0023-9637-08Oxytrol for Women32 in 1 CARTONPATCH327
0023-9637-08Oxytrol for Women4 d in 1 PATCHPATCH47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9637OXYTROL FOR WOMEN (OXYBUTYNIN) PATCH [ALLERGAN, INC.]7Current NDC, Legacy NDC, 4 package rows20250109_8cdc5b4d-ff8d-4010-97d7-313422a0b868.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9637-04EA - Each0023-963737642404-e98d-40ac-a2c1-985cd0ee49af12020-02-13
0023-9637-08EA - Each0023-9637d665755a-2d3f-4a15-8e3c-978fafad4c8412019-11-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-96370023-9637-04, 0023-9637-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBUTYNINK9P6MC7092ACTIB
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202211-001OXYTROL FOR WOMENOXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2584e616aacf4f…
2026-08-18 06:07:402026-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253f01610625f2…
2019-09-15 20:21 UTC2019-09N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N202211-00167434412020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812492020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812502020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812512020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812522020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00171794832020-04-26U-132974a2ff9319b5…
2020-12-22 03:56 UTC2020-12N202211-00167434412020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812492020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812502020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812512020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812522020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00171794832020-04-26U-13298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202211-00167434412020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812492020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812502020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812512020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812522020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00171794832020-04-26U-1329c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202211-00167434412020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812492020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812502020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812512020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812522020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00171794832020-04-26U-13293f01610625f2…
2019-09-15 20:21 UTC2019-09N202211-00167434412020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812492020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812502020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812512020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812522020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00171794832020-04-26U-1329b00525d2431f…
2019-07-19 19:46 UTC2019-07N202211-00167434412020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812492020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812502020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812512020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812522020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00171794832020-04-26U-1329ea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxytrol for WomenOXYBUTYNINAllergan, Inc.8cdc5b4d-ff8d-4010-97d7-313422a0b8682024-08-15WarningsExact identifier
ndc (package): 0023-9637-04
ndc (package): 0023-9637-08
ndc (product): 0023-9637
ndc11 (package): 00023963704
ndc11 (package): 00023963708
spl id: cc404430-2345-4294-8efc-e1e996cc17b2
spl set id: 8cdc5b4d-ff8d-4010-97d7-313422a0b868

Reported adverse events (FAERS/openFDA)#

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