FDA.reportPublic FDA data

Senna

Product NDC
71399-1017
11-digit product format
713991017
Labeler code
71399
Product ID
71399-1017_35428dd1-59c5-58f3-e063-6394a90af628
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-06
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
Senna
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
55ce3969-d7a6-49c4-8c13-d95690efc1a6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-1017-1Senna100 in 1 BOTTLETABLET1005
71399-1017-2Senna1000 in 1 BOTTLETABLET10005
71399-1017-3Senna1 in 1 PACKETTABLET15
71399-1017-3Senna100 in 1 PACKAGETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1017-1EA - Each71399-10176b657b1f-5e35-4b42-8959-f64f2a6e9ca112025-02-10
71399-1017-2EA - Each71399-10177f670a52-1666-410f-8f70-717f9fa7082e12025-02-10
71399-1017-3EA - Each71399-1017c94aa22c-526b-497c-b061-aef3042ab24112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-1017SENNA (SENNOSIDES) TABLET [AKRON PHARMA INC.]5Current NDC, 4 package rows20250519_55ce3969-d7a6-49c4-8c13-d95690efc1a6.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 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
312935sennosides 8.6 MG Oral TabletPSN55ce3969-d7a6-49c4-8c13-d95690efc1a65
312935sennosides, USP 8.6 MG Oral TabletSCD55ce3969-d7a6-49c4-8c13-d95690efc1a65
312935sennosides A and B 8.6 MG Oral TabletSY55ce3969-d7a6-49c4-8c13-d95690efc1a65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-1017-171399101701100 TABLET in 1 BOTTLE (71399-1017-1) 100 tablet2024-12-06NoNoCurrent
71399-1017-2713991017021000 TABLET in 1 BOTTLE (71399-1017-2) 1000 tablet2024-12-06NoNoCurrent
71399-1017-371399101703100 PACKET in 1 PACKAGE (71399-1017-3) / 1 TABLET in 1 PACKET100 packet2024-12-06NoNoCurrent