Home NDC 58914-080 Bentyl
Product NDC 58914-080
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 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 · 4 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 58914-080-52 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 58914-080-52 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FREE DICYCLOMINE HYDROCHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1984-10-15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 2 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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