Application 008370
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENTYL | DICYCLOMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
| 002 | BENTYL PRESERVATIVE FREE | DICYCLOMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
Orange Book products#
| 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FREE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-10-15 |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.
| 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N008370-002 | BENTYL PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-10-15 | 84e616aacf4f… | |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N008370-002 | BENTYL PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-10-15 | caaa826d4ba7… | |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#
| 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… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 6d7e73b0-3f7e-462f-92eb-cc82919c8095 | 2026-09-10 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | REMEDYREPACK INC. | 62be6437-db8c-431b-8e5f-780487cf2d43 | 2026-09-09 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | REMEDYREPACK INC. | e67ad329-6395-4fa0-a898-f13959034e26 | 2026-09-04 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | REMEDYREPACK INC. | 7ff96d1f-fb87-4244-a697-1d93e10eb738 | 2026-08-21 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Major Pharmaceuticals | 5eee0dff-d157-4534-adfb-c035b7042c07 | 2026-08-20 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Redpharm Drug | 594b6832-a31c-4de2-e063-6294a90a05fa | 2026-08-18 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | REMEDYREPACK INC. | 2c36b79f-153c-446c-899b-6e28ccff1dc8 | 2026-08-18 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Redpharm Drug | 58e713f9-6412-0a1a-e063-6394a90a91b6 | 2026-08-13 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Cardinal Health 107, LLC | 793a3f0c-ea45-4e28-a98a-610cf9eddad8 | 2026-08-12 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9d249073-0171-4bb0-8cad-13cb3713159f | 2026-08-12 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | de44e605-14a3-4b40-bf1b-2ac857eb7b12 | 2026-08-12 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Lannett Company, LLC | bd2cba10-70ec-4d1f-b46c-53d1de2ee130 | 2026-08-06 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Redpharm Drug | 57e5f041-9a6e-9d0c-e063-6294a90ab54c | 2026-07-31 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | Advagen Pharma Ltd., | a66aa5c7-1fde-42fc-9e1f-7f4cc9adac9c | 2026-07-22 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 3dc0f4f0-ee38-4f9b-abb6-6395215fe524 | 2026-07-16 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 4da6868f-3530-4960-af71-e56439c96e9f | 2026-07-14 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | Bryant Ranch Prepack | 34db5a80-f445-41e5-b3c4-4c18abb09c92 | 2026-07-14 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine hydrochloride | DICYCLOMINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 41aed1c9-b32f-3694-e063-6394a90a29e4 | 2026-06-25 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | AvPAK | 141d3818-7a87-aaa0-e063-6294a90a4866 | 2026-06-23 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
| Dicyclomine Hydrochloride | DICYCLOMINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 1b2d5256-b75d-11f8-e063-6394a90ae9ed | 2026-06-23 | Warnings, Adverse reactions | DICYCLOMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4553 | Bentyl | Dicyclomine hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-4553 | Bentyl | Dicyclomine hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-4553 | Bentyl | Dicyclomine hydrochloride | A-S Medication Solutions | NDA | Current |
| 58914-080 | Bentyl | Dicyclomine hydrochloride | Allergan, Inc. | NDA | Current |
| 58914-080 | Bentyl | Dicyclomine hydrochloride | Allergan, Inc. | NDA | Current |
| 58914-080 | Bentyl | Dicyclomine hydrochloride | Allergan, Inc. | NDA | Current |
| 58914-080 | Bentyl | Dicyclomine hydrochloride | Allergan, Inc. | NDA | Current |