Docu Liquid

Product NDC: 50383-349
11-digit product format: 503830349
Labeler code: 50383
Product ID: 50383-349_5ac421b1-7808-4afb-8e1c-706b77b0e090
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: LIQUID
Route: ORAL
Labeler: Akorn Operating Company LLC
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1997-08-01
Marketing end: 0000-00-00
Substance: DOCUSATE SODIUM
Active strength: 50 mg/5mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50383-349		I	Inactivated by FDA		2026-10-05
excluded package	package	50383-349	50383-349-11	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-349-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-349-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-349-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-349-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-349-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-349-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-349-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-349-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-349-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-349-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-349-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-349-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-349-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-349-11	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-349-11	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-349-11	2024-01-30	C162847	48780-1	1030e364-fd2b-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-349-10	Docu Liquid	10 mL in 1 CUP, UNIT-DOSE	LIQUID	10	9
50383-349-11	Docu Liquid	10 in 1 TRAY	LIQUID	10	9
50383-349-11	Docu Liquid	10 in 1 CASE	LIQUID	10	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-349-10	ML - Milliliter	50383-349	b04e14fb-0732-4d09-8963-56e894cc5683	1	2021-07-15
50383-349-11	ML - Milliliter	50383-349	2b1627ec-43db-4e48-962a-02e845d117a2	1	2021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
DOCUSATE	ACTIVE MOIETY	M7P27195AG	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
POLOXAMER 181	INACTIVE INGREDIENT	09Y8E6164A	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-349	DOCU LIQUID (DOCUSATE SODIUM) LIQUID [AKORN OPERATING COMPANY LLC]	9	Legacy NDC, 3 package rows	20221015_7fdc4368-4888-4792-86d3-c8a828e4fff2.zip

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	7fdc4368-4888-4792-86d3-c8a828e4fff2	9
1248119	docusate sodium 10 MG/ML Oral Suspension	SCD	7fdc4368-4888-4792-86d3-c8a828e4fff2	9
1248119	docusate sodium 100 MG per 10 ML Oral Suspension	SY	7fdc4368-4888-4792-86d3-c8a828e4fff2	9
1248119	docusate sodium 150 MG per 15 ML Oral Suspension	SY	7fdc4368-4888-4792-86d3-c8a828e4fff2	9
1248119	docusate sodium 50 MG per 5 ML Oral Suspension	SY	7fdc4368-4888-4792-86d3-c8a828e4fff2	9
1248119	DOSS Sodium 10 MG/ML Oral Suspension	SY	7fdc4368-4888-4792-86d3-c8a828e4fff2	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-349-10	50383034910	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical
50383-349-11	50383034911	10 TRAY in 1 CASE (50383-349-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-349-10)	10 tray	2021-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Cardinal Health 107, LLC	2023-11-15	HUMAN OTC DRUG LABEL	2
Drug Facts	Akorn Operating Company LLC	2022-10-13	HUMAN OTC DRUG LABEL	9