FDA.reportPublic FDA data

Application 018967

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION200MG/100MLNoNo
002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION400MG/100MLNoNo
003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION800MG/100MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTION1984-03-30
N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE400MG/100MLINJECTABLE / INJECTION1984-03-30
N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE800MG/100MLINJECTABLE / INJECTION1984-03-30

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.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30c2088c7a36db…
2026-10-15 13:18:302026-09N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30c2088c7a36db…
2026-10-15 13:18:302026-09N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30c2088c7a36db…
2026-09-14 22:38:342026-08N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-3084e616aacf4f…
2026-09-14 22:38:342026-08N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-3084e616aacf4f…
2026-09-14 22:38:342026-08N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-3084e616aacf4f…
2026-08-18 06:07:402026-07N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018967-002LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTION1984-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018967-003LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTION1984-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018967-001LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION1984-03-3079d66fd596c7…

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.

Matched openFDA labels page 5 of 15 · 299 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPrecision Dose, Inc.27b6ef54-a093-2bef-e063-6394a90a79122025-12-29Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
WALGREENS BURNLIDOCAINE HYDROCHLORIDEWALGREENSb61e6d73-4f41-ef50-e053-2a95a90a0fc62025-12-29WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme with Lidocaine Foot Pain CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.da82cc0e-cc39-408e-87e1-c35bb6f9f51e2025-12-19WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution38560997-cfe4-2f9b-e063-6394a90a834b2025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2c33e5-290e-2f89-e063-6394a90aee692025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42caf92e-6fa9-5bd7-e063-6294a90a39042025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2bdb1f-f1c0-370d-e063-6294a90a5c502025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC4643042c-ec95-3bad-e063-6294a90a82502025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECardinal Health 107, LLC4e46cac7-00cd-4a01-ba11-9af4960cfbe92025-12-18Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
POMG NIGHT TIME PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDEPOMG LLC28d7dfb0-a94c-90de-e063-6294a90a036a2025-12-02WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEBrookfield Pharmaceuticals, LLC.e824ba5b-3289-5ad4-e053-2995a90acc202025-11-27Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEA-S Medication Solutions82b377ee-0e3e-4cb9-a644-f45434c21cca2025-11-26Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42df73b0-20ee-d1aa-e063-6294a90aa2752025-11-21Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDEDextrum Laboratories, Inc441daa6f-f273-ac09-e063-6394a90a252c2025-11-21WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.313a7e1f-c1a9-4fa5-bb83-7256c271b3512025-11-17Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHenry Schein, Inc.335dfa50-56f3-4c02-b713-8eef4e28eb452025-11-17Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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