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 40 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	AMERISOURCEBERGEN DRUG CORPORATION	5d690d82-e4fb-57ad-e053-2a91aa0a38ea	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	AMERISOURCEBERGEN DRUG CORPORATION	5d6a8048-93e7-42e5-e053-2991aa0acabd	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	AMERISOURCEBERGEN DRUG CORPORATION	5d7f5a38-4222-5bfb-e053-2991aa0a17e3	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	CARDINAL HEALTH	af4b6b64-97c9-a794-e053-2a95a90aaf0b	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	CARDINAL HEALTH	af5ddf5d-b1f5-2918-e053-2995a90a2d61	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	H E B	ab998776-6b30-9f17-e053-2995a90a96cd	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	H E B	abfe89c8-86f1-bd1e-e053-2995a90af773	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	GOODSENSE	a951617d-c6fa-75e0-e053-2995a90afcf8	2023-11-07	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	KROGER COMPANY	a1b04366-ff67-3bb3-e053-2a95a90a816c	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	BETTER LIVING BRANDS, LLC	b9440381-df40-4bc7-e053-2995a90ae83f	2023-11-07	Warnings	Exact identifier application number: M007
Milk of Magnesia mint	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83f6027-51a0-1730-e053-2995a90a553b	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83eb807-d522-4408-e053-2a95a90a7926	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83f0c1c-0e90-2888-e053-2995a90a0b96	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	DOLGENCORP, INC.	b6991abf-9819-701c-e053-2a95a90ac0b4	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Chain Drug Marketing Association	7722145c-913c-4ed5-a9b2-a6c343064066	2023-11-06	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	Chain Drug Marketing Association	12361478-d178-4950-9458-4e2e56565599	2023-11-06	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750e0355-369e-b679-e053-2a91aa0a66ca	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750efd58-5845-fbc4-e053-2a91aa0a86d1	2023-11-01	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	ba4a29b3-2ddc-b906-e053-2995a90a2ab7	2023-11-01	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	92879e62-f60a-4ab4-9532-610cdd2628ee	2023-11-01	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.	2026-10-16	HUMAN OTC DRUG LABEL	7
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