FDA.reportPublic FDA data

Sennosides

Product NDC
51316-112
11-digit product format
513160112
Labeler code
51316
Product ID
51316-112_4bbdec00-ae8b-f451-e063-6294a90a0467
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-23
Substance
SENNOSIDES
Active strength
8.6 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Sennosides
Listing expiration
2027-12-31

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
0b7736df-c7de-7d00-e063-6294a90aa57eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-112-02Sennosides250 in 1 BOTTLETABLET, FILM COATED2503
51316-112-03Sennosides50 in 1 BOTTLETABLET, FILM COATED503
51316-112-03Sennosides1 in 1 CARTONTABLET, FILM COATED13
51316-112-05Sennosides500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-112SENNOSIDES TABLET, FILM COATED [CVS PHARMACY, INC]2Current NDC, 4 package rows20241208_0b7736df-c7de-7d00-e063-6294a90aa57e.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
312935sennosides 8.6 MG Oral TabletPSN0b7736df-c7de-7d00-e063-6294a90aa57e3
312935sennosides, USP 8.6 MG Oral TabletSCD0b7736df-c7de-7d00-e063-6294a90aa57e3
312935sennosides A and B 8.6 MG Oral TabletSY0b7736df-c7de-7d00-e063-6294a90aa57e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-112-0251316011202250 TABLET, FILM COATED in 1 BOTTLE (51316-112-02) 2023-03-23NoNoCurrent
51316-112-03513160112031 BOTTLE in 1 CARTON (51316-112-03) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-26NoNoCurrent
51316-112-0551316011205500 TABLET, FILM COATED in 1 BOTTLE (51316-112-05) 2023-12-01NoNoCurrent