FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:55:25

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure13 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: 14 mg/ 5 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 flavored liquid supplied in the following: NDC 0121-0935-16: 16 fl oz (473 mL) bottle NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 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

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

  • 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 older5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

• Sodium content: 14 mg/ 5 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 flavored liquid supplied in the following:

NDC 0121-0935-16: 16 fl oz (473 mL) bottle
NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.


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

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

R12/20

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0935-16

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

16 fl oz (473 mL)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

X0935160721 R07/21

16 fl oz (473 mL) bottle label
16 fl oz (473 mL) bottle label

PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0935-05

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

5 mL unit dose cup
5 mL unit dose cup

PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-1870-10

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

10 mL unit dose cup
10 mL unit dose cup

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSN9
1245686docusate sodium 10 MG/ML Oral SolutionSCD9
1245686docusate sodium 10 MG per 1 ML Oral SolutionSY9
1245686docusate sodium 100 MG per 10 ML Oral SolutionSY9
1245686docusate sodium 150 MG per 15 ML Oral SolutionSY9
1245686DOSS Sodium 10 MG/ML Oral SolutionSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0935-05Docusate Sodium5 mL in 1 CUP, UNIT-DOSELIQUID59
0121-0935-16Docusate Sodium473 mL in 1 BOTTLELIQUID4739
0121-0935-40Docusate Sodium10 in 1 TRAYLIQUID109
0121-0935-40Docusate Sodium4 in 1 CASELIQUID49
0121-1870-00Docusate Sodium10 in 1 CASELIQUID109
0121-1870-00Docusate Sodium10 in 1 TRAYLIQUID109
0121-1870-10Docusate Sodium10 mL in 1 CUP, UNIT-DOSELIQUID109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0935DOCUSATE SODIUM LIQUID [PAI HOLDINGS, LLC DBA PAI PHARMA]9Current NDC, Legacy NDC, 4 package rows20250216_e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5.zip
0121-1870DOCUSATE SODIUM LIQUID [PAI HOLDINGS, LLC DBA PAI PHARMA]9Current NDC, Legacy NDC, 3 package rows20250216_e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0935-05ML - Milliliter0121-0935bd4be1fb-4d63-4e7c-8bfa-2e34cd4de1c512021-10-08
0121-0935-16ML - Milliliter0121-09353bdd2684-e7df-4efc-abb2-b74bbcf7d51612021-10-08
0121-0935-40ML - Milliliter0121-09353327600b-3340-46f6-b2a4-f6be1a4545bb12021-10-08
0121-1870-00ML - Milliliter0121-1870a37dd3bc-e001-460a-9a39-74142147442112022-01-06
0121-1870-10ML - Milliliter0121-1870657965f5-d4d5-4d7e-877f-3f3a5647ef5312022-01-06

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
0121-09350121-0935-16, 0121-0935-05, 0121-0935-40
0121-18700121-1870-10, 0121-1870-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL SOLUTION8KW3E207O2IACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL SOLUTION8KW3E207O2IACT

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 SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
ndc (package): 0121-1870-10
ndc (package): 0121-0935-05
ndc (package): 0121-0935-40
ndc (package): 0121-1870-00
ndc (package): 0121-0935-16
ndc (product): 0121-1870
ndc (product): 0121-0935
ndc11 (package): 00121093516
ndc11 (package): 00121093505
ndc11 (package): 00121093540
ndc11 (package): 00121187010
ndc11 (package): 00121187000
spl id: 5cfc4685-c885-4303-a988-5009cbd8e57b
spl set id: e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5

Reported adverse events (FAERS/openFDA)#

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