STOOL SOFTENER

Product NDC: 51013-426
Requested package NDC: 51013-426-48
11-digit product format: 510130426
Labeler code: 51013
Product ID: 51013-426_f7eacd3f-b26a-4e73-b282-67d44e45a956
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: PuraCap Pharmaceutical LLC
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-02-12
Marketing end: 0000-00-00
Substance: DOCUSATE SODIUM
Active strength: 100 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	51013-426	51013-426-48	I	Inactivated by FDA		2026-10-21

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

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
51013-426-48	2025-01-30	C162847	48780-1	2cef2736-7e83-d83d-e063-dadaa90ab31f	STOOL SOFTENER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-426-48	STOOL SOFTENER	10 in 1 BOTTLE	CAPSULE, LIQUID FILLED	10		2
51013-426-48	STOOL SOFTENER	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-426	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	2	Legacy NDC, 2 package rows	20200111_02214159-6028-464a-b933-10d88adb76e7.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	02214159-6028-464a-b933-10d88adb76e7	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	02214159-6028-464a-b933-10d88adb76e7	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	02214159-6028-464a-b933-10d88adb76e7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51013-426-48	51013042648	1 BOTTLE in 1 CARTON (51013-426-48) > 10 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2018-02-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STOOL SOFTENER	PuraCap Pharmaceutical LLC \| Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	2020-01-09	HUMAN OTC DRUG LABEL	2