FDA.reportPublic FDA data

EX-LAX

Product NDC
0067-8142
11-digit product format
000678142
Labeler code
0067
Product ID
0067-8142_2133e636-8bf8-4e31-b653-1ea9dc773e7e
Type
HUMAN OTC DRUG
Nonproprietary name
SENNOSIDES
Dosage form
PILL
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-01
Substance
SENNOSIDES
Active strength
25 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
EX-LAX
Brand name suffix
MAXIMUM STRENGTH STIMULANT LAXATIVE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213073Internal RxNorm lookup
251292Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb170340-c996-46cf-b165-84e136ba4151Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8142-01EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE12 in 1 BLISTER PACKPILL126
0067-8142-01EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE2 in 1 CARTONPILL26
0067-8142-02EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE12 in 1 BLISTER PACKPILL126
0067-8142-02EX-LAXMAXIMUM STRENGTH STIMULANT LAXATIVE4 in 1 CARTONPILL46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8142-01EA - Each0067-8142ff3c59f3-197f-4ec3-af8b-e9e43ff9918e12022-10-06
0067-8142-02EA - Each0067-8142f206bb4d-db09-42d0-83ff-549032b29f6e12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8142EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE (SENNOSIDES) PILL [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20241219_fb170340-c996-46cf-b165-84e136ba4151.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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213073Ex-Lax Maximum Strength 25 MG Oral TabletPSNfb170340-c996-46cf-b165-84e136ba41516
251292sennosides 25 MG Oral TabletPSNfb170340-c996-46cf-b165-84e136ba41516
213073sennosides, USP 25 MG Oral Tablet [Ex-Lax Maximum Relief Formula]SBDfb170340-c996-46cf-b165-84e136ba41516
251292sennosides, USP 25 MG Oral TabletSCDfb170340-c996-46cf-b165-84e136ba41516
213073Ex-Lax Maximum Relief Formula 25 MG Oral TabletSYfb170340-c996-46cf-b165-84e136ba41516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8142-01000678142012 BLISTER PACK in 1 CARTON (0067-8142-01) / 12 PILL in 1 BLISTER PACK2 blister pack2017-07-010000-00-00NoNoCurrent
0067-8142-02000678142024 BLISTER PACK in 1 CARTON (0067-8142-02) / 12 PILL in 1 BLISTER PACK4 blister pack2017-07-010000-00-00NoNoCurrent