FDA.reportPublic FDA data

EX-LAX

Product NDC
0067-8140
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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage0067-8140-01
excluded packagepackage0067-8140-02
excluded packagepackage0067-8140-03

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 39 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPEPharma Nobis, LLCf0488c86-6c74-3987-e053-2a95a90a31b42023-12-22WarningsExact identifier
application number: M007
Mineral Oil HeavyMINERAL OILPharma Nobis, LLCe42f6c6d-c4de-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M007
Quality Choice Castor OilCASTOR OILChain Drug Market Asociation18d7124f-7745-45b2-adc4-cb1103add5d62023-12-20WarningsExact identifier
application number: M007
Premiere Value Castor OilCASTOR OILChain Drug Consortium5c8c1564-fcff-894b-e053-2991aa0a9c0b2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRYBionpharma, Inc.f0fa4b72-50a5-5c42-e053-2995a90a159a2023-12-20WarningsExact identifier
application number: M007
Harris Teeter Castor OilCASTOR OILHarris Teeter, LLC5cca6b4b-d88f-1c7d-e053-2991aa0a051f2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMONBionpharma, Inc.f0f9c36e-c43b-05d2-e053-2995a90a6d652023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPEBionpharma, Inc.f0f9ff19-ae08-0af0-e053-2a95a90ab8422023-12-20WarningsExact identifier
application number: M007
CVS Mineral OilMINERAL OILCVS9d7402e1-524b-1084-e053-2a95a90ae3af2023-12-20WarningsExact identifier
application number: M007
Top Care Castor OilCASTOR OILTOPCO ASSOCIATES LLC8dce1a1f-e765-9c75-e053-2995a90abf9f2023-12-18WarningsExact identifier
application number: M007
Humco Epson SaltMAGNESIUM SULFATEHumco Holding Group, Inc.7a9d1b77-6c39-46f1-86f2-4059dde20f852023-12-15WarningsExact identifier
application number: M007
Humco Mineral Oil HeavyMINERAL OILHumco Holding Group, Inc.9f943fdf-5058-4e18-ba96-6be112bf72ca2023-12-15WarningsExact identifier
application number: M007
Rite Aid Castor OilCASTOR OILRite Aid Corporation.5e0d3664-b01b-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M007
GNP Castor OilCASTOR OILAmerisource Bergen5d06bec6-f1e7-4f0c-e053-2991aa0a8ad82023-12-14WarningsExact identifier
application number: M007
SankaijoDOCUSATE SODIUM, SENNOSIDESSato Pharmaceutical Co., Ltd.83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b2023-11-29WarningsExact identifier
application number: M007
SIMPEX Bisacodyl laxativeBISACODYLSimpex Pharma Pvt. Ltd5114ed64-4fec-401b-8a91-8df3e42b10b12023-11-29WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corpb595063a-5fee-18c2-e053-2a95a90a5b992023-11-15WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPublixcbf7dcef-7623-b333-e053-2a95a90a0f1a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEMeijer, Inc.bb8b51e9-ba4a-270d-e053-2a95a90a318b2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLCff0d4b9f-7ce8-dd98-e053-6394a90ab6142023-11-08WarningsExact 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
0067-8140-01000678140011 PACKAGE in 1 BOX (0067-8140-01) / 12 TABLET, CHEWABLE in 1 PACKAGE1 package2017-08-010000-00-00NoNoCurrent
0067-8140-02000678140022 PACKAGE in 1 BOX (0067-8140-02) / 12 TABLET, CHEWABLE in 1 PACKAGE2 package2017-08-010000-00-00NoNoCurrent
0067-8140-03000678140034 PACKAGE in 1 BOX (0067-8140-03) / 12 TABLET, CHEWABLE in 1 PACKAGE4 package2017-08-010000-00-00NoNoCurrent