FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
American Health Packaging
Effective date
2025-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:37

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Indications and uses

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

Dosage and administration

Dose once daily take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste. adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor

Storage and handling

Sodium content: 28 mg / 10 mL Store at controlled room temperature, 20° to 25°C (68° to 77°F) Protect from freezing Protect from light Clear pink to purple pink colored, cherry-vanilla flavored liquid supplied in the following: 10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL cup)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits 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
  • rash occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Dose once daily
  • take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.

adults and children 12 years and older

5 to 20 mL (1 to 4 teaspoonfuls)

children 6 to under 12 years of age

5 to 10 mL (1 to 2 teaspoonfuls)

children 3 to under 6 years of age

2.5 to 5 mL (1/2 to 1 teaspoonful)

children under 3 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Sodium content: 28 mg / 10 mL
  • Store at controlled room temperature, 20° to 25°C (68° to 77°F)
  • Protect from freezing
  • Protect from light
  • Clear pink to purple pink colored, cherry-vanilla flavored liquid supplied in the following:

10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56

Inactive ingredients:

INACTIVE INGREDIENT SECTION

artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

SPL UNCLASSIFIED SECTION

American Health Packaging
Columbus, OH 43217

R12/24

Principal Display Panel – Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg 10mL Docusate Sodium Liquid Tray.jpg100 mg 10mL Docusate Sodium Liquid Tray.jpg

Case NDC 60687-878-56/Cup NDC 60687-878-42

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

For Institutional Use Only

T0935C101224            R12/24

Principal Display Panel – Cup – 100 mg / 10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg 10mL Docusate Sodium Liquid Lid.jpg100 mg 10mL Docusate Sodium Liquid Lid.jpg

NDC 60687- 878-42

Docusate Sodium
Liquid

Stool Softener Laxative

100 mg/10 mL

Alcohol Free/Sugar Free

Delivers 10 mL

Protect from freezing. Protect from light.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0935C100125

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSN1
1245686docusate sodium 10 MG/ML Oral SolutionSCD1
1245686docusate sodium 10 MG per 1 ML Oral SolutionSY1
1245686docusate sodium 100 MG per 10 ML Oral SolutionSY1
1245686docusate sodium 150 MG per 15 ML Oral SolutionSY1
1245686DOSS Sodium 10 MG/ML Oral SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-878-42Docusate Sodium10 mL in 1 CUP, UNIT-DOSELIQUID101
60687-878-48Docusate Sodium10 in 1 TRAYLIQUID101
60687-878-56Docusate Sodium10 in 1 CASELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-878DOCUSATE SODIUM LIQUID [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20250425_e5028f6d-d33d-47a9-8453-00af5cdf59a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-878-42ML - Milliliter60687-8785ce48099-6623-41c4-857a-bf7c1fb1458312025-05-14
60687-878-56ML - Milliliter60687-878b1bc5e56-c291-4fa8-93ec-f726a85a4cba12025-05-14

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
60687-87860687-878-42, 60687-878-48, 60687-878-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL SOLUTION8KW3E207O2IACT
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
Docusate SodiumDOCUSATE SODIUMAmerican Health Packaginge5028f6d-d33d-47a9-8453-00af5cdf59a62025-04-20WarningsExact identifier
ndc (package): 60687-878-56
ndc (package): 60687-878-48
ndc (package): 60687-878-42
ndc (product): 60687-878
ndc11 (package): 60687087856
ndc11 (package): 60687087842
ndc11 (package): 60687087848
spl id: 328399bd-5afd-f961-e063-6294a90a7c0a
spl set id: e5028f6d-d33d-47a9-8453-00af5cdf59a6

Reported adverse events (FAERS/openFDA)#

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