FDA.reportPublic FDA data

Application 080504

Type
ANDA
Sponsor
BELMORA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%NoNo
004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.01MG/ML;2%NoNo
005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.02MG/ML;2%NoNo

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

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
A080504-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982
A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19
A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1984e616aacf4f…
2026-09-14 22:38:342026-08A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1984e616aacf4f…
2026-08-18 06:07:402026-07A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982301d65b070ca…

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 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
BLACK LABEL B NUMBLIDOCAINE HYDROCHLORIDESCALP TECH INC11fcf401-0891-04bc-e063-6294a90a8ad52026-01-09WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
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
brand name: Lidocaine Hydrochloride
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
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2c33e5-290e-2f89-e063-6394a90aee692025-12-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42caf92e-6fa9-5bd7-e063-6294a90a39042025-12-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2bdb1f-f1c0-370d-e063-6294a90a5c502025-12-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC4643042c-ec95-3bad-e063-6294a90a82502025-12-18Warnings, Adverse reactionsName fallback
brand name: lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECardinal Health 107, LLC4e46cac7-00cd-4a01-ba11-9af4960cfbe92025-12-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
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
brand name: Lidocaine Hydrochloride
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
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42df73b0-20ee-d1aa-e063-6294a90aa2752025-11-21Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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