Bisacodyl

Product NDC: 11534-013
11-digit product format: 115340013
Labeler code: 11534
Product ID: 11534-013_6be65bdd-e94a-4682-9977-043741174c59
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Sunrise Pharmaceutical Inc
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2005-07-08
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	11534-013		I	Inactivated by FDA	2026-08-07
excluded package	package	11534-013	11534-013-01	I	Inactivated by FDA	2026-08-07
excluded package	package	11534-013	11534-013-03	I	Inactivated by FDA	2026-08-07
excluded package	package	11534-013	11534-013-25	I	Inactivated by FDA	2026-08-07

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 · 88 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	11534-013-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11534-013-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11534-013-03	`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	11534-013-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11534-013-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11534-013-03	`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	11534-013-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11534-013-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11534-013-03	`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	11534-013-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11534-013-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11534-013-03	`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	11534-013-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11534-013-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11534-013-03	`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	11534-013-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11534-013-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11534-013-03	`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	11534-013-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11534-013-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11534-013-03	`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	11534-013-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11534-013-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11534-013-03	`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	11534-013-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11534-013-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11534-013-03	`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	11534-013-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11534-013-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11534-013-03	`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	11534-013-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11534-013-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11534-013-03	`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	11534-013-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11534-013-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11534-013-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11534-013-25	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11534-013-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11534-013-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11534-013-25	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11534-013-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11534-013-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11534-013-25	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11534-013-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11534-013-03	`1332a3947898…`	`d4bfe170f9cd…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11534-013-01	2019-10-29	C162847	48780-1	960f7f55-da9c-8e05-e053-dbdaa90a074a	Bisacodyl USP 5 mg Laxative
11534-013-03	2019-10-29	C162847	48780-1	960f7f55-da9c-8e05-e053-dbdaa90a074a	Bisacodyl USP 5 mg Laxative
11534-013-25	2019-10-29	C162847	48780-1	960f7f55-da9c-8e05-e053-dbdaa90a074a	Bisacodyl USP 5 mg Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11534-013-01	Bisacodyl	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100	3
11534-013-03	Bisacodyl	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	3
11534-013-25	Bisacodyl	25 in 1 BOTTLE	TABLET, DELAYED RELEASE	25	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
BISACODYL	ACTIVE MOIETY	10X0709Y6I	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-013	BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]	3	Legacy NDC, 3 package rows	20110815_d497e5a6-625a-49cb-bccb-a5e7da89b451.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	d497e5a6-625a-49cb-bccb-a5e7da89b451	3
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	d497e5a6-625a-49cb-bccb-a5e7da89b451	3
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	d497e5a6-625a-49cb-bccb-a5e7da89b451	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
11534-013-01	11534001301	100 in 1 BOTTLE	Historical
11534-013-03	11534001303	1000 in 1 BOTTLE	Historical
11534-013-25	11534001325	25 in 1 BOTTLE	Historical