FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2023-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:55:38

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure8 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

• do not exceed recommended dose • adults and children 12 years and older: take 1-3 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor • children under 12: consult a doctor

Storage and handling

• each softgel contains: sodium 7 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed recommended dose
• adults and children 12 years and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
• children under 12: consult a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 7 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2534-62025-01-30C16284748780-1f386c64a-31d3-0266-e053-dadaa90a7c1agc 401
68071-2534-62023-07-14C16284748780-1f386c64a-31d3-0266-e053-dadaa90a7c1agc 401
68071-2534-62023-01-30C16284748780-1f386c64a-31d3-0266-e053-dadaa90a7c1agc 401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2534-6Docusate Sodium60 in 1 BOTTLECAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2534DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230715_cbfaa63f-b3cd-d001-e053-2995a90a6b6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-401-01EA - Each57896-401da8e6844-b6ae-4244-8bfc-f7ad99d8eaf812013-06-04
57896-401-03EA - Each57896-4016762957d-d7f6-4213-a664-2c7f42fc9f3612013-06-04
57896-401-10EA - Each57896-4017ae1d03c-6162-4398-b8d2-1946db28e94112013-06-04
57896-401-20EA - Each57896-4018f701acd-94d7-43d2-9072-f8fbf72510af12021-02-05
57896-401-25EA - Each57896-4015c82cab7-f225-43ff-b3f5-38f5ffd4b01a12018-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-253468071-2534-6
57896-401

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MANNITOL3OWL53L36AIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
ndc (product): 57896-401
00757782-048b-668d-e063-6294a90af560cbfaa63f-b3cd-d001-e053-2995a90a6b6d2023-07-14WarningsExact identifier
spl id: 00757782-048b-668d-e063-6294a90af560
spl set id: cbfaa63f-b3cd-d001-e053-2995a90a6b6d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.