Application 018967
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 400MG/100ML | No | No |
| 003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 800MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | ||
| N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | ||
| N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018967-002 | LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018967-003 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 800MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018967-001 | LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | 1984-03-30 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | f0617ab8-555f-4cbe-9795-c922f5ef176e | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | e1badbba-59af-e451-e053-2a95a90a49f8 | 2025-10-30 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC. | 42531a38-7cff-de16-e063-6394a90a18d8 | 2025-10-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | A-S Medication Solutions | e6c83ad7-2821-432b-8610-0f54cfe610cb | 2025-10-21 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Ear Pain MD | LIDOCAINE HYDROCHLORIDE | Eosera Inc | 78c4418f-7f0f-447f-a94f-d4c89a081af1 | 2025-10-17 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Trilocaine | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | c58257bf-f06b-48d1-92df-a680dbd5eea0 | 2025-10-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Trilogel | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | 22af7d63-6a56-4a38-a95b-0f88410b23cb | 2025-10-14 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | The J. Molner Company LLC | 17880468-873f-6465-e063-6294a90a9c73 | 2025-10-06 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 40339593-1142-53ef-e063-6394a90afd4f | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Atlantic Biologicals Corp. | 401ecb6c-392b-1d74-e063-6294a90a4005 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ee21518e-b3ed-405a-ac3b-bfe753893dba | 2025-09-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Medi-First Burn | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 44bb5f25-1114-4bb1-8bcf-40402594abc4 | 2025-09-09 | Warnings | LIDOCAINE HYDROCHLORIDE |
| MediFirst Burn | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9fa5b348-29c2-4cd0-a945-0486bd27f5e0 | 2025-09-08 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8 | 2025-09-08 | Warnings | LIDOCAINE HYDROCHLORIDE |
| HealthWise 4% Lidocaine Cream 2.7 oz | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | f39eb3d0-e153-4f50-85b1-ad5c677d176c | 2025-08-28 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Cintas First Aid & Safety | 96f17095-31f3-4b8a-ab22-0caaefaa7476 | 2025-08-15 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Aruba Aloe Alcoholada | LIDOCAINE HYDROCHLORIDE | Aruba Aloe Balm NV | f56c62b0-75db-4499-858e-54e10b0e140a | 2025-08-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Lannett Company, Inc. | c3353e08-2a8c-4ace-ba89-114f7131b8de | 2025-08-07 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.