Bentyl

Product NDC: 50090-4553
11-digit product format: 500904553
Labeler code: 50090
Product ID: 50090-4553_2d86a401-e4c1-4a86-ac43-a79a9b0574b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: A-S Medication Solutions
Application: NDA008370
Marketing category: NDA
Marketing start: 1952-08-13
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/2mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-4553		D	Discontinued by firm		2026-10-16
excluded package	package	50090-4553	50090-4553-0	D	Discontinued by firm		2026-10-16

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 · 11 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	50090-4553-0	`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	50090-4553-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4553-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4553-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4553-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4553-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4553-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4553-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4553-0	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N008370-001	BENTYL	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15
N008370-002	BENTYL PRESERVATIVE FREE	DICYCLOMINE HYDROCHLORIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1984-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION		RLD	1984-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008370-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008370-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008370-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008370-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008370-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N008370-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008370-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N008370-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008370-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008370-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008370-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N008370-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N008370-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N008370-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008370-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008370-002	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4553-0	2023-02-06	C162847	48780-1	f386c64a-09d0-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENTYL® safely and effectively. See full prescribing information for BENTYL. BENTYL (dicyclomine hydrochloride) injection, for intramuscular use Initial U.S. Approval: 1950
50090-4553-0	2023-01-30	C162847	48780-1	f386c64a-09d0-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENTYL® safely and effectively. See full prescribing information for BENTYL. BENTYL (dicyclomine hydrochloride) injection, for intramuscular use Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4553-0	ML - Milliliter	50090-4553	76ff0622-ec33-44a9-b23d-cf034230c54f	1	2022-12-07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CQ903KQA31	DICYCLOMINE HYDROCHLORIDE	67-92-5	DICYCLOMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4553-0	50090455300	2 mL in 1 AMPULE (50090-4553-0)	2 ml	2019-09-24	0000-00-00	No	No	Current