FDA.reportPublic FDA data

DRUG FACTS

Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
104
Source
full-release
Hydrated at
2026-06-01 01:53:26

Label at a glance#

ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces 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 1-3 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 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

SPL UNCLASSIFIED 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 (1-800-222-1222) 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 overtake 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink


Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

How Supplied Section

Docusate Sodium 100 mg

  • NDC: 71335-9731-1: 30 Capsules in a BOTTLE
  • NDC: 71335-9731-2: 100 Capsules in a BOTTLE
  • NDC: 71335-9731-3: 60 Capsules in a BOTTLE
  • NDC: 71335-9731-4: 120 Capsules in a BOTTLE
  • NDC: 71335-9731-5: 90 Capsules in a BOTTLE
  • NDC: 71335-9731-6: 180 Capsules in a BOTTLE
  • NDC: 71335-9731-7: 10 Capsules in a BOTTLE
  • NDC: 71335-9731-8: 28 Capsules in a BOTTLE
  • NDC: 71335-9731-9: 56 Capsules in a BOTTLE
  • NDC: 71335-9731-0: 18 Capsules in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium 100 mg Capsule

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN104
1115005docusate sodium 100 MG Oral CapsuleSCD104
1115005DOSS Sodium 100 MG Oral CapsuleSY104

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00371335973117(21)0123456789(17)280409(10)208820GTIN-14: 00371335973117
GTIN-12: 371335973117
UPC-A: 371335973117
EAN-13: 0371335973117
GTIN storage (14 digits): 00371335973117		lbl713359731.jpg
QR code linkQR Codedailymed.nlm.nih.gov/dailymed/search.cfm?adv=1&query=NDC:71335-9731-1lbl713359731.jpg
Data codeCode 1287133597311lbl713359731.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9731-0Stool Softener Laxative18 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED18104
71335-9731-1Stool Softener Laxative30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED30104
71335-9731-2Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED100104
71335-9731-3Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED60104
71335-9731-4Stool Softener Laxative120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED120104
71335-9731-5Stool Softener Laxative90 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED90104
71335-9731-6Stool Softener Laxative180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED180104
71335-9731-7Stool Softener Laxative10 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED10104
71335-9731-8Stool Softener Laxative28 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED28104
71335-9731-9Stool Softener Laxative56 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED56104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7280-60EA - Each0904-728026a1e584-5c99-4037-9a6b-ca3b57d707f212023-03-13
0904-7280-80EA - Each0904-7280d88438cf-e71a-4f39-b013-ee79652343c412023-03-13

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-973171335-9731-1, 71335-9731-2, 71335-9731-3, 71335-9731-4, 71335-9731-5, 71335-9731-6, 71335-9731-7, 71335-9731-8, 71335-9731-9, 71335-9731-0
0904-7280

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
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SORBITAN6O92ICV9RUIACT

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
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackd616685a-11fc-4ae0-80de-7d25c0d71ee92026-04-09WarningsExact identifier
ndc (package): 71335-9731-9
ndc (package): 71335-9731-5
ndc (package): 71335-9731-2
ndc (package): 71335-9731-4
ndc (package): 71335-9731-1
ndc (package): 71335-9731-7
ndc (package): 71335-9731-3
ndc (package): 71335-9731-0
ndc (package): 71335-9731-8
ndc (package): 71335-9731-6
ndc (product): 71335-9731
ndc11 (package): 71335973104
ndc11 (package): 71335973109
ndc11 (package): 71335973103
ndc11 (package): 71335973107
ndc11 (package): 71335973101
ndc11 (package): 71335973106
ndc11 (package): 71335973100
ndc11 (package): 71335973105
ndc11 (package): 71335973102
ndc11 (package): 71335973108
spl id: 2f8a60f0-1546-455f-9083-ad4935b0ca01
spl set id: d616685a-11fc-4ae0-80de-7d25c0d71ee9
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals97561cd4-63d9-44c2-a3a3-ec668a09a4ed2025-10-31WarningsExact identifier
ndc (product): 0904-7280

Reported adverse events (FAERS/openFDA)#

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