FDA.reportPublic FDA data

Docusate Sodium and Sennosides

Product NDC
62993-0002
11-digit product format
629930002
Labeler code
62993
Product ID
62993-0002_48f5ab82-91b0-71fa-e063-6294a90a74c9
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium and Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Morepen Laboratories Limited
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; 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
Docusate Sodium and Sennosides
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cf42333-7479-940a-e063-6394a90aedeeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62993-0002-1Docusate Sodium and Sennosides30 in 1 BOTTLETABLET302
62993-0002-2Docusate Sodium and Sennosides60 in 1 BOTTLETABLET602
62993-0002-3Docusate Sodium and Sennosides100 in 1 BOTTLETABLET1002
62993-0002-4Docusate Sodium and Sennosides1000 in 1 BOTTLETABLET10002
62993-0002-5Docusate Sodium and Sennosides3000 in 1 BOTTLETABLET30002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62993-0002-1EA - Each62993-00028de5b6e7-78c1-4e96-a2e3-a59c7a54735212026-05-22
62993-0002-2EA - Each62993-000234e7f982-0b62-47b0-b752-24bf6a12ee2a12026-05-22
62993-0002-3EA - Each62993-00024c536160-78d8-4adc-af74-9fdded62b06512026-05-22

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 38 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)eb7f3d65-8741-407d-b3f3-1d9dda19684d2024-03-05WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f50ba829-16c3-40a7-9822-8d6d00353b332024-02-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)4ce62421-97e0-4920-9a6d-9fa1f0f93fe42024-02-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack851a5dda-e72b-4067-a98f-54d3222f646e2024-02-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)2ca80e23-f38a-4f77-b536-131cc9f0cf5b2024-02-23WarningsExact identifier
application number: M007
Colon DetoxDOCUSATE SODIUM AND SENNOSIDESOPMX LLC0a4d3265-080c-d2ed-e063-6394a90adbee2024-02-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4501d718-15a7-4e27-bdb1-8aa2d3ff06d02024-02-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBest Choice (Valu Merchandisers Company)72bd251b-4e82-41ef-8362-39f95faf99162024-02-15WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMONCARDINAL HEALTH, INC. 06399736010bdd5e6-3db2-8f9e-e063-6394a90a9b3f2024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPECARDINAL HEALTH, INC. 06399736010beb3ec-a189-221d-e063-6394a90aabb52024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCARDINAL HEALTH, INC. 06399736010bebb63-19b3-2e14-e063-6394a90a8d4e2024-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMProficient Rx LPf9ac0344-5864-4ac1-81bc-16878a5946c52024-02-01WarningsExact identifier
application number: M007
Purifi Hand SanitizerBENZALKONIUM CHLORIDEPurifi LLC9267069d-4cf5-4e48-a446-7dbebea16bf52024-01-31WarningsExact identifier
application number: M007
WOMENS LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCARDINAL HEALTHb7b13bfa-8a94-6f62-e053-2995a90abbf42024-01-10WarningsExact identifier
application number: M007
FIBER LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
application number: M007
Freskaro Castor OilCASTOR OILPharma Nobis, LLCfbd6bdd5-a7a1-3f28-e053-6294a90aab872023-12-28WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILPharma Nobis, LLCe42f9d37-1b07-177a-e053-2a95a90a9b062023-12-26WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMONPharma Nobis, LLCf0477328-eca1-9043-e053-2995a90aaa3d2023-12-22WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRYPharma Nobis, LLCf0489f6f-9e60-7d69-e053-2a95a90a9dfb2023-12-22WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3cf42333-7479-940a-e063-6394a90aedee2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3cf42333-7479-940a-e063-6394a90aedee2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3cf42333-7479-940a-e063-6394a90aedee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62993-0002-16299300020130 TABLET in 1 BOTTLE (62993-0002-1) 30 tablet2025-10-01NoNoCurrent
62993-0002-26299300020260 TABLET in 1 BOTTLE (62993-0002-2) 60 tablet2025-10-01NoNoCurrent
62993-0002-362993000203100 TABLET in 1 BOTTLE (62993-0002-3) 100 tablet2025-10-01NoNoCurrent
62993-0002-4629930002041000 TABLET in 1 BOTTLE (62993-0002-4) 1000 tablet2025-10-01NoNoCurrent
62993-0002-5629930002053000 TABLET in 1 BOTTLE (62993-0002-5) 3000 tablet2025-10-01NoNoCurrent