FDA.reportPublic FDA data

Sofdra

Product NDC
83723-010
Requested package NDC
83723-010-50
11-digit product format
837230010
Labeler code
83723
Product ID
83723-010_3f660131-556e-fa6f-e063-6294a90a3dec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sofpironium bromide
Dosage form
GEL
Route
TOPICAL
Labeler
Botanix SB Inc.
Application
NDA217347
Marketing category
NDA
Marketing start
2024-08-06
Substance
SOFPIRONIUM BROMIDE
Active strength
87 mg/.67mL
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 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
N217347-001SOFDRASOFPIRONIUM BROMIDEEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217347-00186287592026-11-13U-23982024-09-26
N217347-00181478092027-03-26Drug substance, Drug product2024-09-26
N217347-001103838462034-03-14U-23982024-09-26
N217347-00192207072034-03-14U-23982024-09-26
N217347-00194924292034-03-14U-2398Drug product2024-09-26
N217347-00198953502034-03-14U-23982024-09-26
N217347-001109471922034-05-22U-23982024-09-26
N217347-001109529902034-05-22U-23982024-09-26
N217347-001109599832034-05-22U-23982024-09-26
N217347-001109611912034-05-22U-23982024-09-26
N217347-001110269192034-05-22U-2398Drug product2024-09-26
N217347-001110346522034-05-22U-2398Drug product2024-09-26
N217347-001110520672034-05-22U-2398Drug product2024-09-26
N217347-001110847882034-05-22U-2398Drug product2024-09-26
N217347-001121568652034-05-22U-2398Drug product2025-06-10
N217347-001123576092034-05-22U-2398Drug product2025-08-14
N217347-001123981022034-05-22U-2398Drug product2025-09-23
N217347-001111233252037-07-20U-2398Drug product2024-09-26
N217347-001115660002040-05-22Drug substance, Drug product2024-09-26
N217347-001115847152040-05-22Drug substance, Drug product2024-09-26
N217347-001127036822040-05-22Drug substance, Drug product2026-09-08

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217347-001NCE2029-06-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-1884e616aacf4f…
2026-08-18 06:07:402026-07N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217347-001SOFDRAEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)GEL, METERED / TOPICALRLD, RS2024-06-18a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 6 · 207 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217347-00186287592026-11-13U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-00181478092027-03-26Drug substance, Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001103838462034-03-14U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-00192207072034-03-14U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-00194924292034-03-14U-2398Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-00198953502034-03-14U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001109471922034-05-22U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001109529902034-05-22U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001109599832034-05-22U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001109611912034-05-22U-23982024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001110269192034-05-22U-2398Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001110346522034-05-22U-2398Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001110520672034-05-22U-2398Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001110847882034-05-22U-2398Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001121568652034-05-22U-2398Drug product2025-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N217347-001123576092034-05-22U-2398Drug product2025-08-1484e616aacf4f…
2026-09-14 22:38:342026-08N217347-001123981022034-05-22U-2398Drug product2025-09-2384e616aacf4f…
2026-09-14 22:38:342026-08N217347-001111233252037-07-20U-2398Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001115660002040-05-22Drug substance, Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001115847152040-05-22Drug substance, Drug product2024-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N217347-001127036822040-05-22Drug substance, Drug product2026-09-0884e616aacf4f…
2026-08-18 06:07:402026-07N217347-00186287592026-11-13U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-00181478092027-03-26Drug substance, Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001103838462034-03-14U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-00192207072034-03-14U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-00194924292034-03-14U-2398Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-00198953502034-03-14U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001109471922034-05-22U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001109529902034-05-22U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001109599832034-05-22U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001109611912034-05-22U-23982024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001110269192034-05-22U-2398Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001110346522034-05-22U-2398Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001110520672034-05-22U-2398Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001110847882034-05-22U-2398Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001121568652034-05-22U-2398Drug product2025-06-10caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001123576092034-05-22U-2398Drug product2025-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001123981022034-05-22U-2398Drug product2025-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001111233252037-07-20U-2398Drug product2024-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N217347-001115660002040-05-22Drug substance, Drug product2024-09-26caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217347-001NCE2029-06-2084e616aacf4f…
2026-08-18 06:07:402026-07N217347-001NCE2029-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217347-001NCE2029-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217347-001NCE2029-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217347-001NCE2029-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217347-001NCE2029-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217347-001NCE2029-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217347-001NCE2029-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217347-001NCE2029-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217347-001NCE2029-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217347-001NCE2029-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217347-001NCE2029-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217347-001NCE2029-06-2079d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217347-001NCE2029-06-20a50c72e98297…

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
Sofdra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOFPIRONIUM BROMIDE87 mg/.67mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7B2Y1932XUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2689326Internal RxNorm lookup
2689332Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78f86f4f-658c-468b-bd54-49182ddcc7acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d8d8035-dcd3-456f-aa16-399db7575739Product name120250226

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83723-010-50Sofdra1 in 1 CARTONGEL16
83723-010-50Sofdra50 mL in 1 BOTTLEGEL506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83723-010-50ML - Milliliter83723-0101603fd21-0352-4e1d-9430-0cc4c54beabe12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83723-010SOFDRA (SOFPIRONIUM BROMIDE) GEL [BOTANIX SB INC.]5Current NDC, 2 package rows20240828_78f86f4f-658c-468b-bd54-49182ddcc7ac.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SofdraSOFPIRONIUM BROMIDEBotanix SB Inc.78f86f4f-658c-468b-bd54-49182ddcc7ac2025-09-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 217347
application number: NDA217347
ndc (package): 83723-010-50
ndc (product): 83723-010
ndc11 (package): 83723001050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2689332Sofdra 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 ActuationsPSN78f86f4f-658c-468b-bd54-49182ddcc7ac6
2689326sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 ActuationsPSN78f86f4f-658c-468b-bd54-49182ddcc7ac6
268933260 ACTUAT sofpironium 72 MG/ACTUAT Topical Gel [Sofdra]SBD78f86f4f-658c-468b-bd54-49182ddcc7ac6
268932660 ACTUAT sofpironium 72 MG/ACTUAT Topical GelSCD78f86f4f-658c-468b-bd54-49182ddcc7ac6
268933260 ACTUAT Sofdra 72 MG/ACTUAT Topical GelSY78f86f4f-658c-468b-bd54-49182ddcc7ac6
2689332Sofdra 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 ActuationsSY78f86f4f-658c-468b-bd54-49182ddcc7ac6
2689326sofpironium 12.45 % (72 MG/ACTUAT) Topical Gel Pump, 60 ActuationsSY78f86f4f-658c-468b-bd54-49182ddcc7ac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83723-010-50837230010501 BOTTLE in 1 CARTON (83723-010-50) / 50 mL in 1 BOTTLE1 bottle2024-08-06NoNoCurrent