Stool Softener Laxative

Product NDC: 63868-638
11-digit product format: 638680638
Labeler code: 63868
Product ID: 63868-638_43425455-08ef-401f-a486-eb9f5da92148
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-12-30
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 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
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	63868-638-25	`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	63868-638-25	`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	63868-638-25	`bd6a592717d7…`	`303034d00443…`

Additional Listing Data#

Finished product: Yes
Brand name base: Stool Softener Laxative
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F05Q2T2JA0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96c7f8bc-be95-40d1-9977-44b7cc6582df	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-638-25	2022-12-14	C162847	48780-1	d6a99b39-4c94-a426-e053-dadaa90af4c2	Drug Facts
63868-638-25	2022-01-28	C162847	48780-1	d6a99b39-4c94-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-638-25	Stool Softener Laxative	250 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	250		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-638	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	3	Current NDC, Legacy NDC, 1 package rows	20240423_96c7f8bc-be95-40d1-9977-44b7cc6582df.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 44 · 874 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salt	MAGNESIUM SULFATE	Cardinal Health, 110 dba Leader	d27dc1cc-5e17-40d3-84fe-c1792552cfd5	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ccec364a-3135-4a5d-b4b0-86b832387b4e	2026-08-24	Warnings	Exact identifier application number: M007
Colace	DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	a1591da0-a1a9-9583-3cf5-788b8fee3814	2026-08-24		Exact identifier application number: M007
MiraFAST soft chews	MAGNESIUM HYDROXIDE	Bayer HealthCare LLC.	2cee67dd-b71f-32b8-e063-6394a90ae864	2026-08-21	Warnings	Exact identifier application number: M007
Senokot-S	STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	c24cdc5e-62e0-41a6-8afb-512202a569f4	2026-08-21	Warnings	Exact identifier application number: M007
Epsom Salt	EPSOM SALT	AmerisourceBergen (Good Neighbor Pharmacy) 46122	d22fb02f-09c4-476a-b6d6-d3a2fd30049d	2026-08-18	Warnings	Exact identifier application number: M007
CVS Stool Softener Fruit Punch	DOCUSATE SODIUM	CVS PHARMACY, INC	0e6900d6-7dc9-47d6-a006-1695feb8d5a5	2026-08-17	Warnings	Exact identifier application number: M007
CVS Senna Laxative	SENNOSIDES	CVS PHARMACY	5a5565b2-827f-4fcc-a835-d827f62da8f9	2026-08-17	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	306fd12b-ed60-40dc-a5be-2dc394bd29d2	2026-08-17	Warnings	Exact identifier application number: M007
CVS Health Childrens Saline Laxative	MAGNESIUM HYDROXIDE	CVS PHARMACY,INC.	e57e5529-2190-4c66-8397-bc2848739e59	2026-08-14	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	Morepen Bio Inc	562d1b9a-09d8-92fc-e063-6394a90a1993	2026-08-14	Warnings	Exact identifier application number: M007
CVS Health	NATURAL FIBER SUPPLEMENT	CVS Pharmacy,Inc.	04dbe9aa-ed18-4d76-a840-d010445a8643	2026-08-14	Warnings	Exact identifier application number: M007
CVS Fiber Therapy	METHYLCELLULOSE	CVS PHARMACY	e066f5bd-5f34-4e04-beec-3c7d6db49381	2026-08-13	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	92f2147d-b52d-4282-b217-28f6095dca0e	2026-08-12	Warnings	Exact identifier application number: M007
CAREONE Orange Flavored	PSYLLIUM HUSK	FOODHOLD USA	4b1cccd2-e941-4d51-9924-4ca35e3a4429	2026-08-11	Warnings	Exact identifier application number: M007
CAREONE	PSYLLIUM HUSK	FOODHOLD USA	3ec3ead0-382e-4765-bbe8-b21e7c7b42a6	2026-08-11	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f4671579-aed0-4f93-ab83-248e0d72b5b0	2026-08-10	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM.50MG/5ML	Aldama Pharmaceuticals, Inc	492b6d37-47cf-3a28-e063-6294a90a2a18	2026-08-10	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Safeway Inc	0b757160-f9eb-4413-9b43-97544c49c72f	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M007
Sennosides	SENNOSIDES	Cardinal Health 107, LLC	4a9e1cbe-ffe4-462f-a86d-078a357dcf49	2026-08-07	Warnings	Exact identifier application number: M007

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	96c7f8bc-be95-40d1-9977-44b7cc6582df	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	96c7f8bc-be95-40d1-9977-44b7cc6582df	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	96c7f8bc-be95-40d1-9977-44b7cc6582df	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-638-25	63868063825	250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (63868-638-25)	2021-12-30	0000-00-00	No	No	Current