Y LAX DR

Product NDC: 68210-0001
11-digit product format: 682100001
Labeler code: 68210
Product ID: 68210-0001_bc82778e-46c6-4bc3-86f8-c6209faeb8bf
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68210-0001		I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0001	68210-0001-2	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0001	68210-0001-3	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0001	68210-0001-4	I	Inactivated by FDA	2026-10-05
excluded package	package	68210-0001	68210-0001-5	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 2 · 110 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	68210-0001-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0001-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0001-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68210-0001-4	`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	68210-0001-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0001-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0001-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68210-0001-4	`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	68210-0001-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0001-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0001-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68210-0001-4	`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	68210-0001-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0001-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0001-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68210-0001-4	`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	68210-0001-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0001-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0001-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68210-0001-4	`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	68210-0001-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0001-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0001-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68210-0001-4	`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	68210-0001-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0001-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0001-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68210-0001-4	`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	68210-0001-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0001-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0001-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68210-0001-4	`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	68210-0001-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0001-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0001-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68210-0001-4	`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	68210-0001-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0001-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0001-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68210-0001-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-0001-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-0001-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-0001-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68210-0001-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-0001-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-0001-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-0001-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68210-0001-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
68210-0001-2	Y LAX TABLETS DR, 5 mg-SUGAR COATED: YELLOW
68210-0001-3	Y LAX TABLETS DR, 5 mg-SUGAR COATED: YELLOW
68210-0001-4	Y LAX TABLETS DR, 5 mg-SUGAR COATED: YELLOW
68210-0001-5	Y LAX TABLETS DR, 5 mg-SUGAR COATED: YELLOW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-0001-2	Y LAX DR	250000 in 1 BAG	TABLET, SUGAR COATED	250000	1
68210-0001-2	Y LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0001-3	Y LAX DR	300000 in 1 BAG	TABLET, SUGAR COATED	300000	1
68210-0001-3	Y LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0001-4	Y LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0001-4	Y LAX DR	350000 in 1 BAG	TABLET, SUGAR COATED	350000	1
68210-0001-5	Y LAX DR	1 in 1 DRUM	TABLET, SUGAR COATED	1	1
68210-0001-5	Y LAX DR	50000 in 1 BAG	TABLET, SUGAR COATED	50000	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	Y 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
68210-0001	Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]	1	Legacy NDC, 8 package rows	20100501_eed05b38-4133-44c4-9b3e-81a04555a218.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	eed05b38-4133-44c4-9b3e-81a04555a218	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	eed05b38-4133-44c4-9b3e-81a04555a218	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	eed05b38-4133-44c4-9b3e-81a04555a218	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68210-0001-2	68210000102	250000 in 1 BAG	Historical
68210-0001-3	68210000103	300000 in 1 BAG	Historical
68210-0001-4	68210000104	1 in 1 DRUM	Historical
68210-0001-5	68210000105	1 in 1 DRUM	Historical

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