Docusate Sodium

Product NDC: 45802-486
11-digit product format: 458020486
Labeler code: 45802
Product ID: 45802-486_15d8cf99-c44d-459f-91ca-7fd089897869
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-10-28
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Docusate Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F05Q2T2JA0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bce3b245-ec47-4e62-9cad-bb12d0812c18	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-486-78	Docusate Sodium	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-486-78	EA - Each	45802-486	efff330d-ac0a-4908-8da3-b9e544bfb324	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
DOCUSATE	ACTIVE MOIETY	M7P27195AG	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PERRIGO NEW YORK INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-486	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PADAGIS ISRAEL PHARMACEUTICALS LTD]	5	Current NDC, Legacy NDC, 1 package rows	20240817_bce3b245-ec47-4e62-9cad-bb12d0812c18.zip

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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Oil	MINERAL OIL	United Natural Foods, Inc. dba UNFI	cb7bc571-295f-47c2-ae93-18cba194752c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Strategic Sourcing Services LLC	e4965086-dcc0-4b34-bb30-81facf7139f3	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Valu Merchandisers Company	cd3e5836-b2f0-41f3-8623-3105c4642491	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Valu Merchandisers Company	a693f6b0-0679-4609-9ca0-dddfa4158c02	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Valu Merchandisers Company	fb358bc3-e479-42e7-8aea-a6a3676f2430	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Valu Merchandisers Company	ff539c1c-9ed3-49be-9b30-1858f12e1e90	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	United Natural Foods, Inc. dba UNFI	bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Walgreens SmoothLAX Soft Chews	MAGNESIUM HYDROXIDE	Walgreens	424e27ce-0b11-9cd2-e063-6294a90a3c21	2026-02-16	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	da013c15-3531-4dc5-b122-bfc99bc494ae	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	db1bc651-1a35-4f92-a917-c6a19f421594	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	The Kroger Co.	e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b	2026-02-13	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	b2ec06b3-647d-49ab-a392-6db63d96d1e3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Topco Associates LLC	5643f2e0-93e2-4c2e-90a0-fd152150d18a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Topco Associates LLC	d3cc7cb6-098e-413c-b1ad-7ebf5fa35269	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Topco Associates LLC	bc89c4bc-5207-479d-9a3b-e570b412a7ba	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	72f69aa0-381a-4e5c-975d-3a73fdc1b377	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Topco Associates LLC	e9b1fd61-c229-4529-82c2-d6ac5b076082	2026-02-13	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Pinnacle RX LLC	4abbb0e4-e005-bc4e-e063-6394a90a126a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
365 Whole Foods Market Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market, Inc.	4147cdd0-57f6-3857-e063-6394a90afecb	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Your Military Exchanges	27cff497-123c-424a-9c43-57740c00168b	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	122486e9-74dd-4181-97d1-0b07688280f4	5
1115005	docusate sodium 100 MG Oral Capsule	PSN	bce3b245-ec47-4e62-9cad-bb12d0812c18	5
1115005	docusate sodium 100 MG Oral Capsule	SCD	122486e9-74dd-4181-97d1-0b07688280f4	5
1115005	docusate sodium 100 MG Oral Capsule	SCD	bce3b245-ec47-4e62-9cad-bb12d0812c18	5
1115005	DOSS Sodium 100 MG Oral Capsule	SY	122486e9-74dd-4181-97d1-0b07688280f4	5
1115005	DOSS Sodium 100 MG Oral Capsule	SY	bce3b245-ec47-4e62-9cad-bb12d0812c18	5
1115005	docusate sodium 100 MG Oral Capsule	PSN	4e30b602-1ac2-48e6-a8b0-fd1dc97a3f48	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	4e30b602-1ac2-48e6-a8b0-fd1dc97a3f48	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	4e30b602-1ac2-48e6-a8b0-fd1dc97a3f48	3
1115005	docusate sodium 100 MG Oral Capsule	PSN	f4236180-d2bc-3a1e-e053-2a95a90a84b9	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	f4236180-d2bc-3a1e-e053-2a95a90a84b9	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	f4236180-d2bc-3a1e-e053-2a95a90a84b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-486-78	45802048678	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (45802-486-78)	2008-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Docusate Sodium 100 mg Drug Facts	Preferred Pharmaceuticals Inc.	2026-04-08	HUMAN OTC DRUG LABEL	3
Docusate Sodium 100 mg Drug Facts	A-S Medication Solutions	2024-11-06	HUMAN OTC DRUG LABEL	5
Padagis Docusate Sodium 100 mg Drug Facts	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-17	HUMAN OTC DRUG LABEL	11
Docusate Sodium 100 mg Drug Facts	Padagis Israel Pharmaceuticals Ltd	2024-08-15	HUMAN OTC DRUG LABEL	5
Perrigo Docusate Sodium 100 mg Drug Facts	Redpharm Drug, Inc.	2023-02-07	HUMAN OTC DRUG LABEL	1
Perrigo Docusate Sodium 100 mg Drug Facts	REMEDYREPACK INC.	2021-09-15	HUMAN OTC DRUG LABEL	3