FDA.reportPublic FDA data

EX-LAX

Product NDC
0067-8140
Requested package NDC
0067-8140-03
11-digit product format
000678140
Labeler code
0067
Product ID
0067-8140_0add1e20-57d2-4642-81ab-a356989ea677
Type
HUMAN OTC DRUG
Nonproprietary name
SENNOSIDES
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-01
Substance
SENNOSIDES
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0067-81400067-8140-03IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES15 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
213071Internal RxNorm lookup
251020Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59a26a7f-516f-4507-8dec-f40cf6cfaffcAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0067-8140-012020-11-18Drug Facts
0067-8140-022020-11-18Drug Facts
0067-8140-032020-11-18Drug Facts
0067-8140-012020-01-31Drug Facts
0067-8140-022020-01-31Drug Facts
0067-8140-032020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8140-01EX-LAXREGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE12 in 1 PACKAGETABLET, CHEWABLE126
0067-8140-01EX-LAXREGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE1 in 1 BOXTABLET, CHEWABLE16
0067-8140-02EX-LAXREGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE2 in 1 BOXTABLET, CHEWABLE26
0067-8140-02EX-LAXREGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE12 in 1 PACKAGETABLET, CHEWABLE126
0067-8140-03EX-LAXREGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE12 in 1 PACKAGETABLET, CHEWABLE126
0067-8140-03EX-LAXREGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE4 in 1 BOXTABLET, CHEWABLE46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8140-01EA - Each0067-8140ef645ac1-a019-404b-9c71-1bf42c10702412025-05-14
0067-8140-02EA - Each0067-8140dbe00176-bc5b-4c64-8e5a-7e5959799d5c12020-04-20
0067-8140-03EA - Each0067-81407695f527-3920-488e-97a5-76861ba357bf12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8140EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE (SENNOSIDES) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 6 package rows20241219_59a26a7f-516f-4507-8dec-f40cf6cfaffc.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 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENOKOTSTANDARDIZED SENNAA-S Medication Solutions0c6e6bdd-9f49-4550-b60a-8f58b7c0f0902026-09-09WarningsExact identifier
application number: M007
BisacodylBISACODYLKROGER COMPANYa13a8eec-3652-8c57-e053-2995a90aaebf2026-09-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
application number: M007
fiber laxativePSYLLIUM HUSKRaritan Pharmaceuticals Inc22e927bd-5734-424e-8870-1aaa18f1265e2026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC5e5749f7-074e-4bbc-9f33-5090e603fdb42026-09-08WarningsExact identifier
application number: M007
Bisacodyl Stimulant LaxativeBISACODYLRaritan Pharmaceuticals Incb99c1a6d-3034-4822-8540-210179c068572026-09-08WarningsExact identifier
application number: M007
Daily Fiber Sugar FreePSYLLIUM HUSKRaritan Pharmaceuticals Inc9c4c41d8-a2d5-4168-9e97-9f9d47fc5e632026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC56c7f197-f01a-4611-a761-cda18da6eed02026-09-08WarningsExact identifier
application number: M007
Sennosides 8.6 mgSENNOSIDESMorepen Bio Inc562c9f11-0ba1-011d-e063-6394a90a604a2026-09-05WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
application number: M007
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Senna Laxative Regular StrengthSENNOSIDESKROGER COMPANYdbb040bb-21f9-43e8-9705-689aeee4d04c2026-09-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAkron Pharma Inc.27fa8f54-ed84-4afd-8da3-8754da48643b2026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INC44c87bbc-2507-4b87-a74b-02f4acb30cf42026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INCe6de00e6-dd81-4aab-af23-04fab261c6ff2026-09-01WarningsExact identifier
application number: M007
EZ2Go Magnesium Citrate Saline Laxative Lemon FlavorMAGNESIUM CITRATEValley Medical Products LLC5a71e88c-d8cc-a8bb-e063-6294a90af4f72026-09-01WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILTHE KROGER CO.d6856f59-ccc3-40fc-9bf1-7a5394ed12da2026-09-01WarningsExact identifier
application number: M007
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Association583b64e7-e48d-6ba6-e063-6294a90ad4d72026-08-28Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213071Ex-Lax Regular Strength Chocolated 15 MG Chewable TabletPSN59a26a7f-516f-4507-8dec-f40cf6cfaffc6
251020sennosides 15 MG Chewable TabletPSN59a26a7f-516f-4507-8dec-f40cf6cfaffc6
213071sennosides, USP 15 MG Chewable Tablet [Ex-Lax Chocolated]SBD59a26a7f-516f-4507-8dec-f40cf6cfaffc6
251020sennosides, USP 15 MG Chewable TabletSCD59a26a7f-516f-4507-8dec-f40cf6cfaffc6
213071Ex-Lax Chocolated 15 MG Chewable TabletSY59a26a7f-516f-4507-8dec-f40cf6cfaffc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8140-03000678140034 PACKAGE in 1 BOX (0067-8140-03) / 12 TABLET, CHEWABLE in 1 PACKAGE4 package2017-08-010000-00-00NoNoCurrent