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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stratuscare Glycerin Laxative Pediatric	GLYCERIN	Stratus Pharmaceuticals	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	2024-11-01	Warnings	Exact identifier application number: M007
Rite Aid Fiber Therapy	METHYLCELLULOSE	RITE AID CORPORATION	e50cea80-c020-4b85-b61f-d053f11f479b	2024-10-30	Warnings	Exact identifier application number: M007
Rite Aid Fiber Caplets	CALCIUM POLYCARBOPHIL	RITE AID CORPORATION	06e46cb0-2928-479e-984d-2305fff995e0	2024-10-30	Warnings	Exact identifier application number: M007
Premier Value Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	2d580965-2bef-46ee-8532-fbe34330a4b4	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy	METHYLCELLULOSE	PHARMACY VALUE ALLIANCE, LLC	b875d5f8-02f3-4474-9fda-83091bc7de04	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Original Coarse	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	8c85a13d-ae99-4599-9a28-c3965caa6376	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value	CALCIUM POLYCARBOPHIL	PHARMACY VALUE ALLIANCE, LLC	4d766548-00d0-41bd-bb58-b69e037c77e2	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber	PSYLLIUM HUSK	Chain Drug Consortium, LLC	c507fe4a-1f8e-4780-a2f5-9da6e5922bef	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	85651bd7-e959-4455-a5ed-bd0223ce0563	2024-10-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c61c71-9a23-4bd3-e053-2a95a90ad460	2024-10-26	Warnings	Exact identifier application number: M007
Pedia-Lax	GLYCERIN	C.B. Fleet Company, Inc.	ae367381-7146-4307-823d-2bb44c1d4200	2024-10-25	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	f7309f4a-f1f5-420e-bfc7-fb4495a5afba	2024-10-24	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	2540ae39-2218-0f6a-e063-6294a90a5efc	2024-10-24	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	Sam's West Inc	b0e99ebb-41fc-459f-86d2-f0e3527f97b0	2024-10-24	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	A-S Medication Solutions	ef05ad45-7082-43e6-9533-a79c5aa0f373	2024-10-22	Warnings	Exact identifier application number: M007
Bliss GVS Children	GLYCERIN	Bliss GVS Pharma Limited	03237ed2-265f-4acd-b504-d82b9263287c	2024-10-17	Warnings	Exact identifier application number: M007
NATURAL Epsom Salt	MAGNESIUM SULFATE	Universal Distribution Center LLC	b2682e51-ffa4-4556-b2a6-b0dbd543fd4f	2024-10-16	Warnings	Exact identifier application number: M007
Bliss GVS	GLYCERIN	Bliss GVS Pharma Limited	1a3982a1-9ce9-4a1a-ba73-ebe2d8647109	2024-10-10	Warnings	Exact identifier application number: M007
Bisacodyl	BISACODYL	Padagis US LLC	7eada0fc-5f83-43da-a56f-b0f537298208	2024-10-10	Warnings	Exact identifier application number: M007
exchange select stool softener	DOCUSATE SODIUM	Army & Air Force Exchange Service	14985848-d791-42b9-ad7e-810a85bb1ee1	2024-10-07	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