FDA.reportPublic FDA data

DOCUSATE SODIUM

Manufacturer
Safecor Health, LLC
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:40

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure7 sections

Label contents#

Full prescribing information#

Active Ingredient (in each 5 mL = 1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Use:

INDICATIONS & USAGE SECTION

Relief of occasional constipation

WARNINGS:

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. 

These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

DOSAGE & ADMINISTRATION SECTION

Directions:

* Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
* Shake well before using
* Do not exceed recommended dose
* May be taken in one to four equally divided oral doses each day
* Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response

Adults and children 12 years of age and over5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor
Children 6 to 12 years of age4 mL to 15 mL (3 teaspoons) or as directed by a doctor
Children 3 to 6 years of age2 mL to 6 mL or as directed by a doctor
Children under 3 years of age1 mL to 4 mL or as directed by a doctor

1 teaspoon = 5 mL

OTHER SAFETY INFORMATION

Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions
between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.

INACTIVE INGREDIENT SECTION

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified
water, sodium benzoate, sodium citrate, and sucralose.

NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204                                                   Rev: 11/2020 PN5473

3 4843322010 8

Principal Display Panel - Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFECOR
HEALTH
Docusate Sodium Liquid
100 mg / 10 ml
Contains 40 (10 ml) Unit Dose Cups

See monograph for complete drug information.

NDC: 48433-220-40
QTY: 40
Lot: 21A0079
Exp: 2023-03-31

Store at room temperature 20°C-25°C (68°F-77°F);
excursions between 15°C-30°C (59°F-86°F) are allowed.
Protect from excessive heat. Protect from light.
This package design is not child resistant. For institutional use only.
Shake well before use.

3 48433 22040 5
Pkg By: Safecor Health, LLC Columbus, OH 43204
Questions or Comments: Call 1-800-447-1006

GTIN: 00348433220405
SN: 212802331
Exp; 2023-03-31
Lot 21A0079 PN5689.C

Principal Display Panel - Box LabelPrincipal Display Panel - Box Label

Principal Display Panel - Lid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 1 0 mL

NDC 48433-220-10

Docusate

Sodium Liquid

100 mg/10mL

SHAKE WELL

348433220108

Pkg By: Safecor Health, LLC

Columbus, OH 43204

PN5618.B

Principal Display Panel - Lid LabelPrincipal Display Panel - Lid Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN3
1248119docusate sodium 10 MG/ML Oral SuspensionSCD3
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY3
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY3
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY3
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48433-220-102023-01-31C16284748780-1f386c649-d87d-0266-e053-dadaa90a7c1aSAFECOR HEALTH Docusate Sodium Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-220-10DOCUSATE SODIUM10 mL in 1 CUP, UNIT-DOSELIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-220DOCUSATE SODIUM LIQUID [SAFECOR HEALTH, LLC]3Current NDC, Legacy NDC, 1 package rows20250110_efe4bf81-fb99-4755-aa23-4f8df5973be8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-220-10ML - Milliliter48433-2209184ffe3-708c-47a6-b2d9-0ce1419e907012023-03-13
54859-813-16ML - Milliliter54859-81325502fa9-6f5b-4d15-898f-034a45e4599b12025-05-14

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
48433-22048433-220-10
54859-813

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
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
METHYLPARABENA2I8C7HI9TIACT
POLOXAMER 1241S66E28KXAIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

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
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact identifier
ndc (product): 54859-813
DOCUSATE SODIUMDOCUSATE SODIUMSafecor Health, LLCefe4bf81-fb99-4755-aa23-4f8df5973be82025-01-08WarningsExact identifier
ndc (package): 48433-220-10
ndc (product): 48433-220
ndc11 (package): 48433022010
spl id: 3b918dfb-629d-4eef-ba71-d2ee2f97747f
spl set id: efe4bf81-fb99-4755-aa23-4f8df5973be8

Reported adverse events (FAERS/openFDA)#

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