Phillips Stool Softener

Product NDC: 0280-1012
11-digit product format: 002801012
Labeler code: 0280
Product ID: 0280-1012_4523911f-9d9b-4b0c-e063-6394a90ac76d
Type: HUMAN OTC DRUG
Nonproprietary name: docusate sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-02
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0280-1012	0280-1012-60	D	Discontinued by firm		2026-10-15

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0280-1012-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0280-1012-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0280-1012-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0280-1012-05	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0280-1012-05	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Phillips Stool Softener
Brand name suffix: Bulk Docusate
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115005	Internal RxNorm lookup
1248002	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
b0462555-5554-4a17-a1fe-4206a4fd350d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0280-1012-30	Phillips Stool SoftenerBulk Docusate	30 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	30	14
0280-1012-30	Phillips Stool SoftenerBulk Docusate	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	14
0280-1012-60	Phillips Stool SoftenerBulk Docusate	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	14
0280-1012-60	Phillips Stool SoftenerBulk Docusate	60 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	60	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
DOCUSATE	ACTIVE MOIETY	M7P27195AG	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0280-1012	PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]	13	Current NDC, Legacy NDC, 4 package rows	20241027_b0462555-5554-4a17-a1fe-4206a4fd350d.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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Extra Strength	DOCUSATE SODIUM	MEIJER, INC.	e43bd2ed-17c7-4530-af72-81a7ad70069c	2023-10-12	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Care One (Retail Business Services, LLC.)	9adaec97-43e3-48f2-96c8-c508b693676c	2023-10-05	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	TopCo Associates, LLC	83aeb90a-ab00-4e26-aa44-5259dce59018	2021-04-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	9fbe783e-ddd9-445a-852a-00f4ad754880	2021-04-20	Warnings	Exact identifier application number: M007
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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	b0462555-5554-4a17-a1fe-4206a4fd350d	14
1248002	Phillips' Stool Softener 100 MG Oral Capsule	PSN	b0462555-5554-4a17-a1fe-4206a4fd350d	14
1248002	docusate sodium 100 MG Oral Capsule [Phillips Stool Softener]	SBD	b0462555-5554-4a17-a1fe-4206a4fd350d	14
1115005	docusate sodium 100 MG Oral Capsule	SCD	b0462555-5554-4a17-a1fe-4206a4fd350d	14
1115005	DOSS Sodium 100 MG Oral Capsule	SY	b0462555-5554-4a17-a1fe-4206a4fd350d	14
1248002	DOSS Sodium 100 MG Oral Capsule [Phillips Stool Softener]	SY	b0462555-5554-4a17-a1fe-4206a4fd350d	14
1248002	Phillips Stool Softener 100 MG Oral Capsule	SY	b0462555-5554-4a17-a1fe-4206a4fd350d	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0280-1012-30	00280101230	1 BOTTLE, PLASTIC in 1 CARTON (0280-1012-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2015-05-19	0000-00-00	No	No	Current
0280-1012-60	00280101260	1 BOTTLE, PLASTIC in 1 CARTON (0280-1012-60) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2015-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phillips ® ' Stool Softener Liquid Gels	Bayer HealthCare LLC.	2025-12-04	HUMAN OTC DRUG LABEL	14