FDA.reportPublic FDA data

Vegetable Laxative

Product NDC
63868-579
11-digit product format
638680579
Labeler code
63868
Product ID
63868-579_ee98cbea-8190-4f89-93ec-0432e9fb7b8a
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-08
Substance
SENNOSIDES
Active strength
8.6 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
Vegetable Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8184a555-4ee1-45b0-8751-f34662997837Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-579-01Vegetable Laxative100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
63868-579-01Vegetable Laxative1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-579-01EA - Each63868-579030338c8-888f-4517-ae98-a11efb59563d12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-579VEGETABLE LAXATIVE (SENNOSIDES) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5Current NDC, Legacy NDC, 2 package rows20241206_8184a555-4ee1-45b0-8751-f34662997837.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
Vegetable LaxativeSENNOSIDESCHAIN DRUG MARKETING ASSOCIATION INC8184a555-4ee1-45b0-8751-f346629978372025-12-15WarningsExact identifier
ndc (product): 63868-579

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSN8184a555-4ee1-45b0-8751-f346629978376
312935sennosides, USP 8.6 MG Oral TabletSCD8184a555-4ee1-45b0-8751-f346629978376
312935sennosides A and B 8.6 MG Oral TabletSY8184a555-4ee1-45b0-8751-f346629978376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-579-01638680579011 BOTTLE, PLASTIC in 1 CARTON (63868-579-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2020-12-080000-00-00NoNoCurrent