Bentyl

Product NDC: 58914-080
Requested package NDC: 58914-080-52
11-digit product format: 589140080
Labeler code: 58914
Product ID: 58914-080_ec446514-48c3-4261-bfbb-c5a71e2e8a66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Allergan, Inc.
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58914-080	58914-080-52	D	Discontinued by firm		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 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58914-080	58914-080-52	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58914-080	58914-080-52	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 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…`
2019-12-13 00:20 UTC	2019-12	N008370-001	BENTYL	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008370-002	BENTYL PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1984-10-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008370-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008370-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008370-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008370-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008370-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008370-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008370-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008370-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008370-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008370-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008370-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008370-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008370-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008370-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008370-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008370-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008370-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008370-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008370-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N008370-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008370-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N008370-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008370-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N008370-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008370-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N008370-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008370-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N008370-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008370-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N008370-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008370-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008370-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008370-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N008370-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008370-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N008370-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008370-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008370-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008370-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008370-002	AP	1	`9b2671bbb829…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58914-080-52	ML - Milliliter	58914-080	7285a331-2225-4d98-af1c-50d93609c9be	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dicyclomine hydrochloride	ACTIVE INGREDIENT	CQ903KQA31	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Dicyclomine	ACTIVE MOIETY	4KV4X8IF6V	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Acacia	INACTIVE INGREDIENT	5C5403N26O	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Calcium sulfate	INACTIVE INGREDIENT	WAT0DDB505	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Dibasic calcium phosphate dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Sucrose	INACTIVE INGREDIENT	C151H8M554	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11
Water	INACTIVE INGREDIENT	059QF0KO0R	BENTYL (DICYCLOMINE HYDROCHLORIDE) CAPSULE BENTYL (DICYCLOMINE HYDROCHLORIDE) TABLET BENTYL (DICYCLOMINE HYDROCHLORIDE) INJECTION, SOLUTION [APTALIS PHARMA US, INC.]	11

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
58914-080-52	58914008052	5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE	5 ampule	1952-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bentyl	A-S Medication Solutions	2025-01-06	HUMAN PRESCRIPTION DRUG LABEL	11
Bentyl	Allergan, Inc.	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	21