Docusate Sodium

Product NDC: 72789-274
11-digit product format: 727890274
Labeler code: 72789
Product ID: 72789-274_eac68284-4d35-494b-e053-2995a90af58c
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-02-28
Marketing end: 0000-00-00
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
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	72789-274		D	Discontinued by firm		2026-10-12
excluded package	package	72789-274	72789-274-30	D	Discontinued by firm		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 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	72789-274		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-274	72789-274-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
72789-274-30	EA - Each	72789-274	d51b0bac-1758-4ce4-b79d-8a5f85486871	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-274	DOCUSATE SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8	Legacy NDC	20240719_6591a3ec-e125-4b45-9000-36f8f2221638.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-274-30	72789027430	30 CAPSULE in 1 BOTTLE, PLASTIC (72789-274-30)	30 capsule	2022-10-11	0000-00-00	No	No	Current