FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
70000-0091
11-digit product format
700000091
Labeler code
70000
Product ID
70000-0091_91e9523b-ba92-4e22-b50c-1f798ce0ba96
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-31
Substance
DOCUSATE SODIUM
Active strength
100 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
Stool Softener Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da5ccd75-8a2f-4f90-ae8a-97d81b8579d2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0091-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1007
70000-0091-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2507
70000-0091-3Stool Softener Laxative750 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED7507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0091-1EA - Each70000-00916dad384a-e8d6-414e-9676-91e6b32878c912021-08-05
70000-0091-2EA - Each70000-00919acee37a-b414-496f-8fb2-f534d08dc91912021-08-05
70000-0091-3EA - Each70000-0091a8b21a91-f5e2-41bf-8c55-3a7afd31db2212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0091STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]5Current NDC, Legacy NDC, 3 package rows20240111_da5ccd75-8a2f-4f90-ae8a-97d81b8579d2.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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNda5ccd75-8a2f-4f90-ae8a-97d81b8579d27
1115005docusate sodium 100 MG Oral CapsuleSCDda5ccd75-8a2f-4f90-ae8a-97d81b8579d27
1115005DOSS Sodium 100 MG Oral CapsuleSYda5ccd75-8a2f-4f90-ae8a-97d81b8579d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0091-170000009101100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-1) 2021-01-310000-00-00NoNoCurrent
70000-0091-270000009102250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-2) 2021-01-310000-00-00NoNoCurrent
70000-0091-370000009103750 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0091-3) 2021-01-310000-00-00NoNoCurrent