Bisacodyl

Product NDC: 16103-367
11-digit product format: 161030367
Labeler code: 16103
Product ID: 16103-367_a86fbc38-1f71-4abc-aade-e98304763076
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Pharbest Pharmaceuticals Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2006-01-25
Marketing end: 0000-00-00
Substance: BISACODYL
Active strength: 5 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16103-367		I	Inactivated by FDA	2026-10-15
excluded package	package	16103-367	16103-367-08	I	Inactivated by FDA	2026-10-15
excluded package	package	16103-367	16103-367-17	I	Inactivated by FDA	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 2 · 66 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	16103-367-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16103-367-08	`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	16103-367-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16103-367-08	`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	16103-367-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16103-367-08	`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	16103-367-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16103-367-08	`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	16103-367-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16103-367-08	`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	16103-367-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16103-367-08	`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	16103-367-17	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16103-367-08	`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	16103-367-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16103-367-08	`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	16103-367-17	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16103-367-08	`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	16103-367-17	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16103-367-08	`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	16103-367-17	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16103-367-08	`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	16103-367-17	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16103-367-08	`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	16103-367-17	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16103-367-08	`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	16103-367-17	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16103-367-08	`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	16103-367-17	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16103-367-08	`1332a3947898…`	`d4bfe170f9cd…`
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	16103-367-17	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-367-08	`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	16103-367-17	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-367-08	`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	16103-367-17	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-367-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16103-367-17	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16103-367-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-367-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16103-367-08	`e2bbac7714bc…`	`27bdfed8d636…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-367-08	2020-01-31	C162847	48780-1	9d75b9cf-f26f-f424-e053-dadaa90a57ce	Drug facts
16103-367-17	2020-01-31	C162847	48780-1	9d75b9cf-f26f-f424-e053-dadaa90a57ce	Drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-367-08	Bisacodyl	100 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	100		1
16103-367-17	Bisacodyl	25 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	25		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-367-08	EA - Each	16103-367	5d324daa-f273-4129-97c0-6c278fe83acc	1	2012-07-24
16103-367-17	EA - Each	16103-367	cd0f35b3-1f82-4b2f-a273-010cce32a7be	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-367	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20120625_29156c82-bb48-4356-860c-ca0e9001882e.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	29156c82-bb48-4356-860c-ca0e9001882e	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	29156c82-bb48-4356-860c-ca0e9001882e	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	29156c82-bb48-4356-860c-ca0e9001882e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
16103-367-08	16103036708	100 in 1 BOTTLE, PLASTIC	Historical
16103-367-17	16103036717	25 in 1 BOTTLE, PLASTIC	Historical