Docusate Sodium

Product NDC: 16103-384
11-digit product format: 161030384
Labeler code: 16103
Product ID: 16103-384_53890faa-599b-4959-9eb4-f141abb61a1a
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Pharbest Pharmaceuticals, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2007-01-22
Marketing end: 0000-00-00
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16103-384		I	Inactivated by FDA	2026-10-12
excluded package	package	16103-384	16103-384-08	I	Inactivated by FDA	2026-10-12
excluded package	package	16103-384	16103-384-11	I	Inactivated by FDA	2026-10-12

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 2 · 66 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	16103-384-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16103-384-08	`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	16103-384-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16103-384-08	`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	16103-384-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16103-384-08	`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	16103-384-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16103-384-08	`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	16103-384-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16103-384-08	`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	16103-384-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16103-384-08	`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	16103-384-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16103-384-08	`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	16103-384-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16103-384-08	`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	16103-384-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16103-384-08	`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	16103-384-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-384-08	`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	16103-384-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-384-08	`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	16103-384-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-384-08	`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	16103-384-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-384-08	`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	16103-384-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-384-08	`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	16103-384-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-384-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-384-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-384-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-384-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-384-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-384-11	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-384-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16103-384-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16103-384-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-384-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-384-08	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-384-08	2020-01-31	C162847	48780-1	9d75b9d0-23ce-f424-e053-dadaa90a57ce	Drug Facts
16103-384-11	2020-01-31	C162847	48780-1	9d75b9d0-23ce-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-384-08	Docusate Sodium	100 in 1 BOTTLE	CAPSULE	100		1
16103-384-11	Docusate Sodium	1000 in 1 BOTTLE	CAPSULE	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-384-08	EA - Each	16103-384	361dab52-2147-4914-b73b-9688ea82cfdf	1	2012-07-24
16103-384-11	EA - Each	16103-384	8aad6e39-09d9-41ec-8bdf-69a2b8016118	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Docusate Sodium	ACTIVE INGREDIENT	F05Q2T2JA0	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Docusate Sodium	ACTIVE INGREDIENT	F05Q2T2JA0	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
Docusate	ACTIVE MOIETY	M7P27195AG	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Docusate	ACTIVE MOIETY	M7P27195AG	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	DOCUSATE SODIUM CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-384	DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20100707_64a4d802-0c72-46ce-9c1d-d01947523669.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
1115005	docusate sodium 100 MG Oral Capsule	PSN	0e96c2fb-21b3-4a49-96fd-51efb872342d	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	0e96c2fb-21b3-4a49-96fd-51efb872342d	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	0e96c2fb-21b3-4a49-96fd-51efb872342d	2
1115005	docusate sodium 100 MG Oral Capsule	PSN	64a4d802-0c72-46ce-9c1d-d01947523669	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	64a4d802-0c72-46ce-9c1d-d01947523669	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	64a4d802-0c72-46ce-9c1d-d01947523669	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
16103-384-08	16103038408	100 in 1 BOTTLE	Historical
16103-384-11	16103038411	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-04-22	HUMAN OTC DRUG LABEL	2
Drug Facts	A-S Medication Solutions	2017-09-27	HUMAN OTC DRUG LABEL	8
Drug Facts	Pharbest Pharmaceuticals, Inc. \| Pharbest Pharmaceuticals, Inc \| Accucaps Industries Ltd.	2010-07-06	HUMAN OTC DRUG LABEL	1