FDA.reportPublic FDA data

Docusate Sodium 250mg

Manufacturer
Olds Softgels Inc.
Effective date
2020-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:04:47

Label at a glance#

ProductDocusate Sodium 250mg
Active ingredientDOCUSATE SODIUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

Docusate Sodium 250 mg

OTC - PURPOSE SECTION

IMPORTANT

This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Olds SoftGels Inc

DOSAGE & ADMINISTRATION SECTION

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

WARNINGS SECTION

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Red No. 40

Granular FD and C

Yellow No.6

Granular

Gelatin

Glycerin USP 99 Percent

Polyethylene

Glycol 400 USP PEG 400

Propylene glycol

Purified water

Sorbitol special GC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABELPACKAGE LABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69160-003-012022-01-28C16284748780-19d75b9d1-1c86-f424-e053-dadaa90a57ce3324cde5-69be-1e89-e054-00144ff8d46c
69160-003-012020-04-02C16284748780-19d75b9d1-1c86-f424-e053-dadaa90a57ce3324cde5-69be-1e89-e054-00144ff8d46c
69160-003-012020-01-31C16284748780-19d75b9d1-1c86-f424-e053-dadaa90a57ce3324cde5-69be-1e89-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69160-003-01Docusate Sodium 250mg7000 in 1 BOXCAPSULE70002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69160-003DOCUSATE SODIUM 250MG (DOCUSATE SODIUM) CAPSULE [OLDS SOFTGELS INC.]2Legacy NDC, 1 package rows20200403_3324cde5-69be-1e89-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69160-00369160-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a2521c80-c652-64a1-e053-2a95a90afd9e3324cde5-69be-1e89-e054-00144ff8d46c2020-04-02WarningsExact identifier
spl id: a2521c80-c652-64a1-e053-2a95a90afd9e
spl set id: 3324cde5-69be-1e89-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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