Docusate Sodium

Manufacturer: Pharbest Pharmaceuticals, Inc. | Pharbest Pharmaceuticals, Inc | Accucaps Industries Ltd.
Effective date: 2010-07-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:25:03

Label at a glance#

ProductDocusate Sodium

Active ingredientDocusate Sodium

Label structure8 sections

Indications and uses

prevents/relieves dry hard stool results usually occurs 1 to 3 days after the first dose

Dosage and administration

do not exceed recommended dose adults and children over 12 years take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter children 6 to 12 years take 1 softgel daily children under 6 years consult a doctor

Contacts and useful links#

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

prevents/relieves dry hard stool
results usually occurs 1 to 3 days after the first dose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

are taking mineral oil
have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have no bowel movement after 3 days
you have rectal bleeding

These could be signs of a serious condition

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

do not exceed recommended dose

adults and children over 12 years	take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years	take 1 softgel daily
children under 6 years	consult a doctor

Other information

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature 15^oto 30^oC (59^o to 86^oF)
protect from moisture

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

1000 SOFTGELS

100 mg each

Image of Docusate label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-384-08	2020-01-31	C162847	48780-1	9d75b9d0-23ce-f424-e053-dadaa90a57ce	Drug Facts
16103-384-11	2020-01-31	C162847	48780-1	9d75b9d0-23ce-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-384-08	Docusate Sodium	100 in 1 BOTTLE	CAPSULE	100		1
16103-384-11	Docusate Sodium	1000 in 1 BOTTLE	CAPSULE	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-384	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20100707_64a4d802-0c72-46ce-9c1d-d01947523669.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-384-08	EA - Each	16103-384	361dab52-2147-4914-b73b-9688ea82cfdf	1	2012-07-24
16103-384-11	EA - Each	16103-384	8aad6e39-09d9-41ec-8bdf-69a2b8016118	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Docusate Sodium	ACTIVE INGREDIENT	F05Q2T2JA0	1
Docusate	ACTIVE MOIETY	M7P27195AG	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Docusate Sodium
Docusate
D&C Yellow No. 10
FD&C Red No. 40
Gelatin
Glycerin
Polyethylene Glycol
Propylene Glycol
Sorbitol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16103-384	16103-384-08, 16103-384-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Docusate Sodium	F05Q2T2JA0	ACTIB
D&C Yellow No. 10	35SW5USQ3G	IACT
FD&C Red No. 40	WZB9127XOA	IACT
Gelatin	2G86QN327L	IACT
Glycerin	PDC6A3C0OX	IACT
Polyethylene Glycol	3WJQ0SDW1A	IACT
Propylene Glycol	6DC9Q167V3	IACT
Sorbitol	506T60A25R	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 303 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	INJECTION / INTRACAVITARY	0.05 ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	ELIXIR / ORAL	0.3 mg/15ml		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	SYSTEM / TOPICAL		1050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii candidate 44 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
53890faa-599b-4959-9eb4-f141abb61a1a			64a4d802-0c72-46ce-9c1d-d01947523669	2010-07-06	Warnings	Exact identifier spl id: 53890faa-599b-4959-9eb4-f141abb61a1a spl set id: 64a4d802-0c72-46ce-9c1d-d01947523669

Reported adverse events (FAERS/openFDA)#

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