Docusate Sodium

Product NDC: 84447-011
11-digit product format: 844470011
Labeler code: 84447
Product ID: 84447-011_335f41d7-5c23-7c17-e063-6294a90a8f28
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: LIQUID
Route: ORAL
Labeler: Belleview Bio Science
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-03-01
Substance: DOCUSATE SODIUM
Active strength: 100 mg/10mL
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/10mL

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
1248119	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
335f41d7-5c22-7c17-e063-6294a90a8f28	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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
84447-011-01	Docusate Sodium	200000 mL in 1 DRUM	LIQUID	200000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84447-011	DOCUSATE SODIUM LIQUID [BELLEVIEW BIO SCIENCE]	1	Current NDC, 1 package rows	20250424_335f41d7-5c22-7c17-e063-6294a90a8f28.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 38 of 42 · 826 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	Best Choice (Valu Merchandisers Company)	72bd251b-4e82-41ef-8362-39f95faf9916	2024-02-15	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	CARDINAL HEALTH, INC. 063997360	10bdd5e6-3db2-8f9e-e063-6394a90a9b3f	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	CARDINAL HEALTH, INC. 063997360	10beb3ec-a189-221d-e063-6394a90aabb5	2024-02-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	CARDINAL HEALTH, INC. 063997360	10bebb63-19b3-2e14-e063-6394a90a8d4e	2024-02-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Proficient Rx LP	f9ac0344-5864-4ac1-81bc-16878a5946c5	2024-02-01	Warnings	Exact identifier application number: M007
Purifi Hand Sanitizer	BENZALKONIUM CHLORIDE	Purifi LLC	9267069d-4cf5-4e48-a446-7dbebea16bf5	2024-01-31	Warnings	Exact identifier application number: M007
WOMENS LAXATIVE ENTERIC COATED	BISACODYL	CARDINAL HEALTH	ab34bc89-6738-d284-e053-2a95a90a5dc9	2024-01-11	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE	SENNOSIDES	CARDINAL HEALTH	b7b13bfa-8a94-6f62-e053-2995a90abbf4	2024-01-10	Warnings	Exact identifier application number: M007
FIBER LAXATIVE	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	e4a921c5-1cf7-12ca-e053-2a95a90a6e04	2024-01-03	Warnings	Exact identifier application number: M007
Freskaro Castor Oil	CASTOR OIL	Pharma Nobis, LLC	fbd6bdd5-a7a1-3f28-e053-6294a90aab87	2023-12-28	Warnings	Exact identifier application number: M007
Humco Castor Oil	CASTOR OIL	Pharma Nobis, LLC	e42f9d37-1b07-177a-e053-2a95a90a9b06	2023-12-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Pharma Nobis, LLC	f0477328-eca1-9043-e053-2995a90aaa3d	2023-12-22	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Pharma Nobis, LLC	f0489f6f-9e60-7d69-e053-2a95a90a9dfb	2023-12-22	Warnings	Exact identifier application number: M007
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Pharma Nobis, LLC	f0488c86-6c74-3987-e053-2a95a90a31b4	2023-12-22	Warnings	Exact identifier application number: M007
Mineral Oil Heavy	MINERAL OIL	Pharma Nobis, LLC	e42f6c6d-c4de-02c6-e053-2995a90a3ace	2023-12-22	Warnings	Exact identifier application number: M007
Quality Choice Castor Oil	CASTOR OIL	Chain Drug Market Asociation	18d7124f-7745-45b2-adc4-cb1103add5d6	2023-12-20	Warnings	Exact identifier application number: M007
Premiere Value Castor Oil	CASTOR OIL	Chain Drug Consortium	5c8c1564-fcff-894b-e053-2991aa0a9c0b	2023-12-20	Warnings	Exact identifier application number: M007
Magnesium Citrate	BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Bionpharma, Inc.	f0fa4b72-50a5-5c42-e053-2995a90a159a	2023-12-20	Warnings	Exact identifier application number: M007
Harris Teeter Castor Oil	CASTOR OIL	Harris Teeter, LLC	5cca6b4b-d88f-1c7d-e053-2991aa0a051f	2023-12-20	Warnings	Exact identifier application number: M007
Magnesium Citrate	BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Bionpharma, Inc.	f0f9c36e-c43b-05d2-e053-2995a90a6d65	2023-12-20	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
1248119	docusate sodium 50 MG in 5 mL Oral Suspension	PSN	331277b8-8304-d082-e063-6394a90a4dd3	1
1248119	docusate sodium 50 MG in 5 mL Oral Suspension	PSN	335f41d7-5c22-7c17-e063-6294a90a8f28	1
1248119	docusate sodium 10 MG/ML Oral Suspension	SCD	331277b8-8304-d082-e063-6394a90a4dd3	1
1248119	docusate sodium 10 MG/ML Oral Suspension	SCD	335f41d7-5c22-7c17-e063-6294a90a8f28	1
1248119	docusate sodium 100 MG per 10 ML Oral Suspension	SY	331277b8-8304-d082-e063-6394a90a4dd3	1
1248119	docusate sodium 100 MG per 10 ML Oral Suspension	SY	335f41d7-5c22-7c17-e063-6294a90a8f28	1
1248119	docusate sodium 150 MG per 15 ML Oral Suspension	SY	331277b8-8304-d082-e063-6394a90a4dd3	1
1248119	docusate sodium 150 MG per 15 ML Oral Suspension	SY	335f41d7-5c22-7c17-e063-6294a90a8f28	1
1248119	docusate sodium 50 MG per 5 ML Oral Suspension	SY	331277b8-8304-d082-e063-6394a90a4dd3	1
1248119	docusate sodium 50 MG per 5 ML Oral Suspension	SY	335f41d7-5c22-7c17-e063-6294a90a8f28	1
1248119	DOSS Sodium 10 MG/ML Oral Suspension	SY	331277b8-8304-d082-e063-6394a90a4dd3	1
1248119	DOSS Sodium 10 MG/ML Oral Suspension	SY	335f41d7-5c22-7c17-e063-6294a90a8f28	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84447-011-01	84447001101	200000 mL in 1 DRUM (84447-011-01)	200000 ml	2025-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docusate Sodium Oral Liquid	Belleview Bio Science	2025-04-22	HUMAN OTC DRUG LABEL	1
Docusate Sodium Oral Liquid	Kesin Pharma Corporation	2025-04-18	HUMAN OTC DRUG LABEL	1