FDA.reportPublic FDA data

DOCUSATE SODIUM 100mg Two-Tone, Capsule, liquid filled

Manufacturer
AmerisourceBergen Drug Corp | Reese Pharmaceutical
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:46

Label at a glance#

ProductGood Neighbor Stool Softener
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Storage and handling

each softgel contains: sodium 5 mg VERY LOW SODIUM store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil, unless told to do so by a doctor                                

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that lasts over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerol, Polyethylene glycol, purified water, sorbitol, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN6
1115005docusate sodium 100 MG Oral CapsuleSCD6
1115005DOSS Sodium 100 MG Oral CapsuleSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-692-72Good Neighbor Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED16
46122-692-72Good Neighbor Stool Softener60 in 1 BOTTLECAPSULE, LIQUID FILLED606
46122-692-78Good Neighbor Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1006
46122-692-85Good Neighbor Stool Softener250 in 1 BOTTLECAPSULE, LIQUID FILLED2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-692GOOD NEIGHBOR STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AMERISOURCEBERGEN DRUG CORP]6Current NDC, Legacy NDC, 4 package rows20241220_88d657a1-77be-412a-9295-034872db2dde.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-692-72EA - Each46122-692c0253fee-86c2-4ec7-b6fb-e2c1e027abfa12022-02-07
46122-692-78EA - Each46122-692ee200c42-86e1-49e9-86e5-909303c5b8c812022-01-06
46122-692-85EA - Each46122-69220707836-2bd1-4baa-9f78-75d0b1e1ca6712022-02-07

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-69246122-692-72, 46122-692-78, 46122-692-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

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
Good Neighbor Stool SoftenerDOCUSATE SODIUMAmerisourceBergen Drug Corp88d657a1-77be-412a-9295-034872db2dde2024-12-18WarningsExact identifier
ndc (package): 46122-692-78
ndc (package): 46122-692-72
ndc (package): 46122-692-85
ndc (product): 46122-692
ndc11 (package): 46122069272
ndc11 (package): 46122069285
ndc11 (package): 46122069278
spl id: 2fdb55e3-1e36-4bbb-8145-06729aea85f2
spl set id: 88d657a1-77be-412a-9295-034872db2dde

Reported adverse events (FAERS/openFDA)#

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