Docusate Sodium

Manufacturer: Rebel Distributors Corp
Effective date: 2011-02-15
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:18

Label at a glance#

ProductDocusate Sodium

Active ingredientDOCUSATE SODIUM

Label structure9 sections

Indications and uses

Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.

Dosage and administration

Adults and children 12 years and older : take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor. Children under 12 : consult a doctor. Do not exceed recommended dose.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

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 way.

Uses

INDICATIONS & USAGE SECTION

Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.

Warnings

WARNINGS SECTION

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.

Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.

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

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor.

Children under 12: consult a doctor.

Do not exceed recommended dose.

Other Information

SPL UNCLASSIFIED SECTION

Each softgel contains sodium 5mg.

Product from Canada or USA

Store at room temperature, 15°C-30°C (59°F-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.

Distributed by:

Geri-Care Pharmaceuticals Corp.

Brooklyn, NY 11204

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium 100mg

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
21695-590-00	2019-09-24	C162847	48780-1	934fe258-4b75-48b1-e053-8cdaa90a720a	Docusate Sodium Drug Facts
21695-590-20	2019-09-24	C162847	48780-1	934fe258-4b75-48b1-e053-8cdaa90a720a	Docusate Sodium Drug Facts
21695-590-30	2019-09-24	C162847	48780-1	934fe258-4b75-48b1-e053-8cdaa90a720a	Docusate Sodium Drug Facts
21695-590-90	2019-09-24	C162847	48780-1	934fe258-4b75-48b1-e053-8cdaa90a720a	Docusate Sodium Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-590-00	Docusate Sodium	100 in 1 BOTTLE	CAPSULE	100	1
21695-590-20	Docusate Sodium	20 in 1 BOTTLE	CAPSULE	20	1
21695-590-30	Docusate Sodium	30 in 1 BOTTLE	CAPSULE	30	1
21695-590-90	Docusate Sodium	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-590	DOCUSATE SODIUM CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20110223_7e23b026-fee4-436a-b378-33d31d6d8b40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-590-00	EA - Each	21695-590	76dba6a4-f128-4141-ab3c-712f30a08c8c	1	2012-07-24
21695-590-20	EA - Each	21695-590	dba98983-168f-46f2-a418-972880ae0888	1	2012-07-24
21695-590-30	EA - Each	21695-590	1d183eef-cdcb-4ce5-a461-92b794647d09	1	2012-07-24
21695-590-90	EA - Each	21695-590	8be4f69c-75dc-4e3c-8bcd-c4952e9102bf	1	2012-07-24
57896-401-01	EA - Each	57896-401	da8e6844-b6ae-4244-8bfc-f7ad99d8eaf8	1	2013-06-04
57896-401-03	EA - Each	57896-401	6762957d-d7f6-4213-a664-2c7f42fc9f36	1	2013-06-04
57896-401-10	EA - Each	57896-401	7ae1d03c-6162-4398-b8d2-1946db28e941	1	2013-06-04
57896-401-20	EA - Each	57896-401	8f701acd-94d7-43d2-9072-f8fbf72510af	1	2021-02-05
57896-401-25	EA - Each	57896-401	5c82cab7-f225-43ff-b3f5-38f5ffd4b01a	1	2018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
ETHYL VANILLIN	INACTIVE INGREDIENT	YC9ST449YJ	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Docusate Sodium
DOCUSATE
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
D&C YELLOW NO. 10
ETHYL VANILLIN
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
MANNITOL
METHYLPARABEN
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
PROPYLPARABEN
SORBITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-590	21695-590-20, 21695-590-30, 21695-590-90, 21695-590-00
57896-401

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
ETHYL VANILLIN	YC9ST449YJ	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
MANNITOL	3OWL53L36A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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 3 · 136 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	TABLET / ORAL		64 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii+route 17 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii+route 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii+route 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii+route 19 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii+route 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	LOZENGE / ORAL		20546 mg	Exact identifier — unii+route 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii+route 17 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii+route 18 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii+route 26 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii+route 19 equally ranked IID candidates
ETHYL VANILLIN	ETHYL VANILLIN	YC9ST449YJ	SYRUP / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii+route 26 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE, FOR SUSPENSION / ORAL		6000 mg	Exact identifier — unii+route 26 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii+route+dosage form
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii+route+dosage form
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii+route 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1568 mg	Exact identifier — unii+route 26 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii+route 26 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 19 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii+route 26 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE / ORAL		1562 mg	Exact identifier — unii+route 26 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii+route 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 18 equally ranked IID candidates
ETHYL VANILLIN	ETHYL VANILLIN	YC9ST449YJ	PASTE / ORAL		7 mg	Exact identifier — unii+route 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii+route 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii+route 24 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TROCHE / ORAL		14594 mg	Exact identifier — unii+route 26 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii+route 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii+route 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii+route 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii+route 17 equally ranked IID candidates
ETHYL VANILLIN	ETHYL VANILLIN	YC9ST449YJ	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii+route 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii+route 19 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii+route 17 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii+route 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii+route 19 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii+route 18 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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier ndc (product): 57896-401
7e23b026-fee4-436a-b378-33d31d6d8b40			7e23b026-fee4-436a-b378-33d31d6d8b40	2011-02-15	Warnings	Exact identifier spl id: 7e23b026-fee4-436a-b378-33d31d6d8b40 spl set id: 7e23b026-fee4-436a-b378-33d31d6d8b40

Reported adverse events (FAERS/openFDA)#

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