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 24 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fleet	BISACODYL	C.B. Fleet Company, Inc.	324e61eb-8f6b-48d7-85c2-b1b5642691c9	2025-06-23	Warnings	Exact identifier application number: M007
Saline Laxative	SODIUM PHOSPHATE	Walgreen Company	fb260df0-7bda-4299-84a5-44c8f9447798	2025-06-18	Warnings	Exact identifier application number: M007
De La Cruz Castor Oil	CASTOR OIL	DLC Laboratories, Inc.	22fbad2e-e9fa-46ba-8617-ad79483cbe9a	2025-06-13	Warnings	Exact identifier application number: M007
Prolaxa	DOCUSATE SODIUM 250MG	Terrain Pharmaceuticals	32610e42-f352-09fd-e063-6394a90abff6	2025-06-12	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Village Pharma	29102014-9b0e-4899-958d-83111f94a612	2025-06-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Power Health, Products, Inc.	364b558b-69b5-bfa4-e063-6294a90acd0c	2025-05-29	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Power Health, Products, Inc.	364bc4f5-6337-6c89-e063-6394a90a12ab	2025-05-29	Warnings	Exact identifier application number: M007
SENNA	SENNOSIDES	AARNA USA INC.	364d4dfc-a089-1a27-e063-6394a90ad77b	2025-05-29	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	Power Health, Products, Inc.	3634b4e4-4fea-9428-e063-6394a90a6ad9	2025-05-28	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA ORIGINAL	MAGNESIUM HYDROXIDE	ATLANTIC BIOLOGICALS CORP.	30fb7b5e-56a3-423e-ae57-432006b54fff	2025-05-23	Warnings	Exact identifier application number: M007
Senna Liquid	SENNA LIQUID	Belleview Biosciences	35d5f217-b101-3cd8-e063-6394a90adccd	2025-05-23	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Walgreens	816c82f8-0fa5-4b22-a226-e8f22f3eaa1d	2025-05-23	Warnings	Exact identifier application number: M007
Senna Laxative	SENNA	PD-Rx Pharmaceuticals, Inc.	2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa	2025-05-21	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Akron Pharma Inc.	55ce3969-d7a6-49c4-8c13-d95690efc1a6	2025-05-16	Warnings	Exact identifier application number: M007
Saline Enema	SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC	Dynarex Corporation	7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5	2025-05-14	Warnings	Exact identifier application number: M007
Bisacodyl	BISACODYL	Rising Pharma Holdings, Inc.	03429da4-1ce9-4789-bf54-ce1b3215b013	2025-05-13	Warnings	Exact identifier application number: M007
COLACE EXTRA STRENGTH STOOL SOFTNER	DOCUSATE SODIUM	Atlantis Consumer Healthcare Inc.	34e06b05-64a5-4b3e-af38-cdcd7c1d521b	2025-05-01	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	PAI Holdings, LLC dba PAI Pharma	7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed	2025-04-28	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Belleview Bio Science	335f41d7-5c22-7c17-e063-6294a90a8f28	2025-04-22	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	American Health Packaging	e5028f6d-d33d-47a9-8453-00af5cdf59a6	2025-04-20	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	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