FDA.reportPublic FDA data

Laxacin

Product NDC
80425-0345
11-digit product format
804250345
Labeler code
80425
Product ID
80425-0345_2a9c2eb6-a6dc-f647-e063-6294a90a93fe
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-19
Substance
DOCUSATE SODIUM; SENNOSIDES A AND B
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Laxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES A AND B8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
1B5FPI42ENInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup
2106884Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe7d4d75-0f8a-1e7d-e053-6394a90afb4dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0345-1Laxacin100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0345-1EA - Each80425-0345e0d5b825-9e4b-4852-9fdc-de636a46689f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0345LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_fe7d4d75-0f8a-1e7d-e053-6394a90afb4d.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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
application number: M007
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
application number: M007
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
application number: M007
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2106884Laxacin 50 MG / 8.6 MG Oral TabletPSNfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
2106884docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SBDfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
2106884DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SYfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
2106884Laxacin 50 MG / 8.6 MG Oral TabletSYfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0345-180425034501100 TABLET in 1 BOTTLE (80425-0345-1) 100 tablet2023-06-19NoNoCurrent