FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
82804-097
11-digit product format
828040097
Labeler code
82804
Product ID
82804-097_4a31ab87-74a2-4354-b2be-f00f62d6cf29
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Proficient Rx LP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-15
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-097-00Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1002
82804-097-30Stool Softener Laxative30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-097-00EA - Each82804-097ac181a64-f456-431a-b5c4-06ef0c00f56612024-06-10
82804-097-30EA - Each82804-09775bd098b-ae3c-49b8-9fef-ac7cb240555f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-097STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PROFICIENT RX LP]2Current NDC, 2 package rows20240904_ccfa095c-77f0-41ff-84f8-e02d983c7c74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsuleSCDccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005DOSS Sodium 100 MG Oral CapsuleSYccfa095c-77f0-41ff-84f8-e02d983c7c742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-097-0082804009700100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (82804-097-00) 2024-04-05NoNoHistorical
82804-097-308280400973030 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (82804-097-30) 2024-08-28NoNoHistorical