P LAX DR

Product NDC: 68210-0002
11-digit product format: 682100002
Labeler code: 68210
Product ID: 68210-0002_5d1f922b-62f7-41e7-849d-6bc036138e59
Type: HUMAN OTC DRUG
Nonproprietary name: BISACODYL
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS,LLC
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-05-01
Marketing end: 0000-00-00
Substance: BISACODYL
Active strength: 5 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68210-0002		I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0002	68210-0002-1	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0002	68210-0002-5	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0002	68210-0002-6	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0002	68210-0002-7	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0002	68210-0002-8	I	Inactivated by FDA	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 3 · 132 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0002-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0002-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0002-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0002-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0002-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0002-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0002-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0002-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0002-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0002-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0002-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0002-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0002-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0002-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0002-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0002-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0002-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0002-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0002-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0002-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0002-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0002-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0002-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0002-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0002-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0002-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0002-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0002-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0002-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0002-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0002-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0002-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0002-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0002-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0002-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0002-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0002-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0002-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0002-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0002-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0002-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0002-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0002-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0002-7	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0002-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0002-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0002-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0002-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0002-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0002-6	`ad56d346431e…`	`cc804d4bbf1e…`

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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68210-0002-1	P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK
68210-0002-5	P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK
68210-0002-6	P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK
68210-0002-7	P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK
68210-0002-8	P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-0002-1	P LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0002-1	P LAX DR	10000 in 1 BAG	TABLET, SUGAR COATED	10000	1
68210-0002-5	P LAX DR	50000 in 1 BAG	TABLET, SUGAR COATED	50000	1
68210-0002-5	P LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0002-6	P LAX DR	65000 in 1 BAG	TABLET, SUGAR COATED	65000	1
68210-0002-6	P LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0002-7	P LAX DR	70000 in 1 BAG	TABLET, SUGAR COATED	70000	1
68210-0002-7	P LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0002-8	P LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0002-8	P LAX DR	80000 in 1 BAG	TABLET, SUGAR COATED	80000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-0002	P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1	Legacy NDC, 10 package rows	20100501_f8c02e1f-4b88-47fc-a720-91deb6a89f52.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10X0709Y6I	BISACODYL	603-50-9	BISACODYL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	f8c02e1f-4b88-47fc-a720-91deb6a89f52	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	f8c02e1f-4b88-47fc-a720-91deb6a89f52	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	f8c02e1f-4b88-47fc-a720-91deb6a89f52	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68210-0002-1	68210000201	1 in 1 DRUM	Historical
68210-0002-5	68210000205	50000 in 1 BAG	Historical
68210-0002-6	68210000206	65000 in 1 BAG	Historical
68210-0002-7	68210000207	70000 in 1 BAG	Historical
68210-0002-8	68210000208	1 in 1 DRUM	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK	SPIRIT PHARMACEUTICALS,LLC \| MISSION VIVACARE LIMITED	2010-04-21	HUMAN OTC DRUG LABEL	1