Application 080210

Type
ANDA
Sponsor
BELMORA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEOINTMENT;TOPICAL5%NoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080210-001LIDOCAINELIDOCAINE5%OINTMENT / TOPICALApproved before 1982

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080210-001LIDOCAINE5%OINTMENT / TOPICALApproved before 1982f41ea6bd6efb…

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 9 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numbing CreamLIDOCAINESainite Trading Shenzhen Co., Ltd.49fcbe81-34b6-5906-e063-6294a90aa65b2026-02-04WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEPHOENIX RX LLC40949067-a5a8-db8c-e063-6294a90af0fb2026-02-04Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEFougera Pharmaceuticals, LLC88ca9cba-0c4a-482f-b502-ceefdb1bfbcd2026-01-28Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Lidocaine Pain ReliefLIDOCAINETrifecta Pharmaceuticals USA, LLC.493c09d0-16d7-7413-e063-6394a90aa0522026-01-26WarningsName fallback
generic name: LIDOCAINE
CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct LargeLIDOCAINECVS PHARMACY, INC4914965f-1164-e20e-e063-6294a90ac2212026-01-23WarningsName fallback
generic name: LIDOCAINE
Equate Pain Relieving Cream LidocaineLIDOCAINEWal-Mart Stores Inc52b91508-22aa-4c4b-94f4-977f14a01dad2026-01-20WarningsName fallback
generic name: LIDOCAINE
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsName fallback
generic name: LIDOCAINE
Black Cobra Tattoo Numbing Cream 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605961a-d596-9c4a-e063-6394a90a99dc2026-01-19WarningsName fallback
generic name: LIDOCAINE
DYNAMO DELAY SAMPLE BOTTLELIDOCAINEMomentum Management LLC05370186-1b82-4d0f-9382-b153252c02212026-01-19WarningsName fallback
generic name: LIDOCAINE
Aspercreme with LidocaineLIDOCAINEChattem, Inc.7ad8efa9-7031-4cd0-be1d-6dee63091fd12026-01-19WarningsName fallback
generic name: LIDOCAINE
TOPCARE PAIN RELIEF PATCHESLIDOCAINETOPCO ASSOCIATES, LLCfa2f7768-e779-4409-aad3-6c33ce2e6b362026-01-18WarningsName fallback
generic name: LIDOCAINE
Aspercreme with Lidocaine XLLIDOCAINEChattem, Inc.b0859b10-539e-4905-ab52-af78b778d6a42026-01-15WarningsName fallback
generic name: LIDOCAINE
Pain Relieving PatchLIDOCAINEFlexiGo Inc.4868af2a-c4be-9c68-e063-6394a90a565b2026-01-15WarningsName fallback
generic name: LIDOCAINE
Careland Lidocaine 4 Pain Relieving Gel-PatchesLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6ca8382-7ce5-4df9-912e-8a0ac04231162026-01-15WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINE 4%AvKARE70aace2f-47b4-e961-e053-2991aa0a63672026-01-14WarningsName fallback
brand name: Lidocaine
LidocaineLIDOCAINEAvKARE0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e2026-01-14Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Aspercreme with Lidocaine Essential Oils Rosemary MintLIDOCAINEChattem, Inc.9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab2026-01-13WarningsName fallback
generic name: LIDOCAINE
THE SOLUTION 2.0LIDOCAINESCALP TECH INC0fa423b6-cc0f-b569-e063-6294a90a239e2026-01-09WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEBellus Medical, LLC60cb89f6-e326-0773-e053-2a91aa0a33dd2026-01-09WarningsName fallback
brand name: Lidocaine
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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