Silace

Product NDC: 54838-116
11-digit product format: 548380116
Labeler code: 54838
Product ID: 54838-116_bb16b285-0ad1-41e8-b59b-3de9ca3936fc
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium
Dosage form: LIQUID
Route: ORAL
Labeler: Lannett Company, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1990-10-05
Marketing end: 2024-11-30
Substance: DOCUSATE SODIUM
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	54838-116		D	Discontinued by firm		2026-10-05
excluded package	package	54838-116	54838-116-80	D	Discontinued by firm		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 · 18 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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`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	54838-116-80	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-116-80	ML - Milliliter	54838-116	8ad43c4d-ee45-4427-bc78-e543e6686759	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
Docusate	ACTIVE MOIETY	M7P27195AG	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
Poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13
water	INACTIVE INGREDIENT	059QF0KO0R	SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]	13

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
1245686	docusate sodium 50 MG in 5 mL Oral Solution	PSN	b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4	3
1245686	docusate sodium 10 MG/ML Oral Solution	SCD	b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4	3
1245686	docusate sodium 10 MG per 1 ML Oral Solution	SY	b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4	3
1245686	docusate sodium 100 MG per 10 ML Oral Solution	SY	b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4	3
1245686	docusate sodium 150 MG per 15 ML Oral Solution	SY	b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4	3
1245686	DOSS Sodium 10 MG/ML Oral Solution	SY	b70aabb5-8b56-40ee-b46e-7eca3bf0bbe4	3
1245686	docusate sodium 50 MG in 5 mL Oral Solution	PSN	6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6	2
1245686	docusate sodium 10 MG/ML Oral Solution	SCD	6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6	2
1245686	docusate sodium 10 MG per 1 ML Oral Solution	SY	6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6	2
1245686	docusate sodium 100 MG per 10 ML Oral Solution	SY	6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6	2
1245686	docusate sodium 150 MG per 15 ML Oral Solution	SY	6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6	2
1245686	DOSS Sodium 10 MG/ML Oral Solution	SY	6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54838-116-80	54838011680	473 mL in 1 BOTTLE, PLASTIC (54838-116-80)	473 ml	1990-10-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Silace Liquid	Lannett Company, Inc.	2018-08-13	HUMAN OTC DRUG LABEL	16
Silace Liquid	Carilion Materials Management	2017-12-28	HUMAN OTC DRUG LABEL	2
Silace Liquid	ATLANTIC BIOLOGICALS CORP.	2016-10-26	HUMAN OTC DRUG LABEL	3