Docusate Sodium

Product NDC: 54629-601
11-digit product format: 546290601
Labeler code: 54629
Product ID: 54629-601_16a5df9c-f9e1-49dc-99cb-b21dfd97e1bf
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: National Vitamin Company
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-05-01
Marketing end: 2027-10-31
Substance: DOCUSATE SODIUM
Active strength: 250 mg/1
NDC exclude flag: No
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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	250 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
1245468	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
0c66642c-82cb-42cd-82bb-5f95852cc5d1	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54629-601-01	2020-04-18	Docusate Sodium, USP Stool Softener
54629-601-99	2020-04-18	Docusate Sodium, USP Stool Softener
54629-601-01	2020-01-31	Docusate Sodium, USP Stool Softener
54629-601-99	2020-01-31	Docusate Sodium, USP Stool Softener

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54629-601-01	Docusate Sodium	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		3
54629-601-99	Docusate Sodium	1000 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54629-601-01	EA - Each	54629-601	e245c595-3a46-46e1-9d19-668930bf45bd	1	2013-02-13
54629-601-99	EA - Each	54629-601	097fce90-d965-4325-ad79-a72f0644601b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54629-601	DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20241228_0c66642c-82cb-42cd-82bb-5f95852cc5d1.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 9 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener plus Stimulant Laxative	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	CARDINAL HEALTH, 110 DBA LEADER	3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce	2026-03-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Walmart Inc.	484d0421-59ea-3783-e063-6394a90af633	2026-03-04	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Walmart Inc.	484c2586-9e6f-1ce5-e063-6394a90a0d81	2026-03-04	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Walmart Inc.	450ddcbd-7ccd-3670-e063-6294a90ac2bd	2026-03-04	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Amazon.com Services LLC	787ec4b0-c6c5-44ab-a53d-d6d25304f95e	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	3d0d63d7-640d-4e54-a6fd-6b265c79be09	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	9b3b6cea-ab83-4b7c-a425-fd0ac7df426c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	51ed515b-cc51-4ea1-b612-090476135005	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Old East Main Co.	a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	629c5817-13b7-4527-8998-93131ee3529e	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	4df97cdc-e7a2-4350-8f95-a679cdcaff64	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	46b26b44-e065-4337-a071-fa036f897140	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Chain Drug Marketing Association	ef163b24-ce92-4cbc-b45a-4fae3b511949	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Marketing Association	4ee26633-8eb1-4c68-a768-20460404533a	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Chain Drug Marketing Association	3bfdad9c-ac58-4e92-b952-555e8a8351cd	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	The Kroger Co.	2bcab227-42b6-4bff-8363-f6800665755b	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	The Kroger Co.	a87dceb2-da73-4d3a-b87c-db2af10471bf	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Kroger Co.	3ae7e275-7bbc-4e62-b30f-013c40a89949	2026-02-27	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	CVS Pharmacy, Inc	0b7736df-c7de-7d00-e063-6294a90aa57e	2026-02-26	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	PD-Rx Pharmaceuticals, Inc.	5d300ea7-78eb-4e19-8333-1e42c73c4c54	2026-02-26	Warnings	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
1245468	docusate sodium 250 MG Oral Capsule	PSN	f31a4349-7826-45c0-9388-6b938d167b7a	9
1245468	docusate sodium 250 MG Oral Capsule	SCD	f31a4349-7826-45c0-9388-6b938d167b7a	9
1245468	DOSS Sodium 250 MG Oral Capsule	SY	f31a4349-7826-45c0-9388-6b938d167b7a	9
1245468	docusate sodium 250 MG Oral Capsule	PSN	6a7e4193-22d2-491e-9842-5c43f571fc65	6
1245468	docusate sodium 250 MG Oral Capsule	SCD	6a7e4193-22d2-491e-9842-5c43f571fc65	6
1245468	DOSS Sodium 250 MG Oral Capsule	SY	6a7e4193-22d2-491e-9842-5c43f571fc65	6
1245468	docusate sodium 250 MG Oral Capsule	PSN	0c66642c-82cb-42cd-82bb-5f95852cc5d1	3
1245468	docusate sodium 250 MG Oral Capsule	SCD	0c66642c-82cb-42cd-82bb-5f95852cc5d1	3
1245468	DOSS Sodium 250 MG Oral Capsule	SY	0c66642c-82cb-42cd-82bb-5f95852cc5d1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54629-601-01	54629060101	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-601-01)	2000-05-01	2027-10-31	No	No	Current
54629-601-99	54629060199	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-601-99)	2000-05-01	2027-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docusate Sodium, USP Stool Softener	PD-Rx Pharmaceuticals, Inc.	2025-02-05	HUMAN OTC DRUG LABEL	6
Docusate Sodium, USP Stool Softener	AvPAK	2025-01-09	HUMAN OTC DRUG LABEL	9
Docusate Sodium, USP Stool Softener	National Vitamin Company	2024-12-12	HUMAN OTC DRUG LABEL	3
Docusate Sodium capsule	Precision Dose, Inc.	2024-01-12	HUMAN OTC DRUG LABEL	2
Docusate Sodium, USP Stool Softener	Safecor Health, LLC	2022-01-26	HUMAN OTC DRUG LABEL	3