Docusate Calcium 240 mg sodium free

Product NDC: 54629-640
Requested package NDC: 54629-640-01
11-digit product format: 546290640
Labeler code: 54629
Product ID: 54629-640_f06f12d6-1c98-4027-87c7-1140a7740490
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate Calcium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: National Vitamin Company
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-02-01
Marketing end: 0000-00-00
Substance: DOCUSATE CALCIUM
Active strength: 240 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54629-640	54629-640-01	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
54629-640-01	2020-04-18	C162847	48780-1	9d75b9cf-ea5c-f424-e053-dadaa90a57ce	Docusate Calcium 240 mg Sodium Free
54629-640-01	2020-01-31	C162847	48780-1	9d75b9cf-ea5c-f424-e053-dadaa90a57ce	Docusate Calcium 240 mg Sodium Free

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54629-640-01	EA - Each	54629-640	e7b360d4-49b7-4263-b874-f0bfa7c4555a	1	2016-07-19

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6K7YS503HC	DOCUSATE CALCIUM	128-49-4	DOCUSATE CALCIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54629-640-01	54629064001	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-640-01)	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docusate Calcium	AvPAK	2023-10-31	HUMAN OTC DRUG LABEL	7
Docusate Calcium 240 mg Sodium Free	National Vitamin Company	2020-04-10	HUMAN OTC DRUG LABEL	2