Docusate Sodium Liquid

Product NDC: 54859-813
11-digit product format: 548590813
Labeler code: 54859
Product ID: 54859-813_4745fe35-8aba-b427-e063-6394a90ab073
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: LIQUID
Route: ORAL
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-12-01
Substance: DOCUSATE SODIUM
Active strength: 50 mg/5mL
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 Liquid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	50 mg/5mL

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
2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-813-16	Docusate Sodium Liquid	473 mL in 1 BOTTLE	LIQUID	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-813-16	ML - Milliliter	54859-813	25502fa9-6f5b-4d15-898f-034a45e4599b	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-813	DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	8	Current NDC, Legacy NDC, 1 package rows	20241228_2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c.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 39 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Magnesium Citrate	BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Bionpharma, Inc.	f0f9ff19-ae08-0af0-e053-2a95a90ab842	2023-12-20	Warnings	Exact identifier application number: M007
CVS Mineral Oil	MINERAL OIL	CVS	9d7402e1-524b-1084-e053-2a95a90ae3af	2023-12-20	Warnings	Exact identifier application number: M007
Top Care Castor Oil	CASTOR OIL	TOPCO ASSOCIATES LLC	8dce1a1f-e765-9c75-e053-2995a90abf9f	2023-12-18	Warnings	Exact identifier application number: M007
Humco Epson Salt	MAGNESIUM SULFATE	Humco Holding Group, Inc.	7a9d1b77-6c39-46f1-86f2-4059dde20f85	2023-12-15	Warnings	Exact identifier application number: M007
Humco Mineral Oil Heavy	MINERAL OIL	Humco Holding Group, Inc.	9f943fdf-5058-4e18-ba96-6be112bf72ca	2023-12-15	Warnings	Exact identifier application number: M007
Rite Aid Castor Oil	CASTOR OIL	Rite Aid Corporation.	5e0d3664-b01b-ba28-e053-2991aa0a8a4c	2023-12-15	Warnings	Exact identifier application number: M007
GNP Castor Oil	CASTOR OIL	Amerisource Bergen	5d06bec6-f1e7-4f0c-e053-2991aa0a8ad8	2023-12-14	Warnings	Exact identifier application number: M007
Sankaijo	DOCUSATE SODIUM, SENNOSIDES	Sato Pharmaceutical Co., Ltd.	83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b	2023-11-29	Warnings	Exact identifier application number: M007
SIMPEX Bisacodyl laxative	BISACODYL	Simpex Pharma Pvt. Ltd	5114ed64-4fec-401b-8a91-8df3e42b10b1	2023-11-29	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	b595063a-5fee-18c2-e053-2a95a90a5b99	2023-11-15	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Publix	cbf7dcef-7623-b333-e053-2a95a90a0f1a	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Meijer, Inc.	bb8b51e9-ba4a-270d-e053-2a95a90a318b	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	STRATEGIC SOURCING SERVICES LLC	ff0d4b9f-7ce8-dd98-e053-6394a90ab614	2023-11-08	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	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	9
1248119	docusate sodium 10 MG/ML Oral Suspension	SCD	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	9
1248119	docusate sodium 100 MG per 10 ML Oral Suspension	SY	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	9
1248119	docusate sodium 150 MG per 15 ML Oral Suspension	SY	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	9
1248119	docusate sodium 50 MG per 5 ML Oral Suspension	SY	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	9
1248119	DOSS Sodium 10 MG/ML Oral Suspension	SY	2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c	9
1248119	docusate sodium 50 MG in 5 mL Oral Suspension	PSN	efe4bf81-fb99-4755-aa23-4f8df5973be8	3
1248119	docusate sodium 10 MG/ML Oral Suspension	SCD	efe4bf81-fb99-4755-aa23-4f8df5973be8	3
1248119	docusate sodium 100 MG per 10 ML Oral Suspension	SY	efe4bf81-fb99-4755-aa23-4f8df5973be8	3
1248119	docusate sodium 150 MG per 15 ML Oral Suspension	SY	efe4bf81-fb99-4755-aa23-4f8df5973be8	3
1248119	docusate sodium 50 MG per 5 ML Oral Suspension	SY	efe4bf81-fb99-4755-aa23-4f8df5973be8	3
1248119	DOSS Sodium 10 MG/ML Oral Suspension	SY	efe4bf81-fb99-4755-aa23-4f8df5973be8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-813-16	54859081316	473 mL in 1 BOTTLE (54859-813-16)	473 ml	2021-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-Ducosate Sodium 813	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2025-12-31	HUMAN OTC DRUG LABEL	9
SAFECOR HEALTH Docusate Sodium Liquid Drug Facts	Safecor Health, LLC	2025-01-08	HUMAN OTC DRUG LABEL	3