FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
37808-878
11-digit product format
378080878
Labeler code
37808
Product ID
37808-878_5f57d4e9-b3d5-497f-9e11-43e244acea11
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-03
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui998740

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-878-12Stool Softener Laxative120 in 1 BOTTLE, PLASTICTABLET1203
37808-878-24Stool Softener Laxative240 in 1 BOTTLE, PLASTICTABLET2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-878STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [H E B]3Current NDC, Legacy NDC, 2 package rows20240410_2f9e2723-53a7-47a8-8c41-87bffc4e50dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2f9e2723-53a7-47a8-8c41-87bffc4e50dd3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2f9e2723-53a7-47a8-8c41-87bffc4e50dd3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2f9e2723-53a7-47a8-8c41-87bffc4e50dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-878-1237808087812120 TABLET in 1 BOTTLE, PLASTIC (37808-878-12) 120 tablet2021-06-030000-00-00NoNoCurrent
37808-878-2437808087824240 TABLET in 1 BOTTLE, PLASTIC (37808-878-24) 240 tablet2021-06-030000-00-00NoNoCurrent