FDA.reportPublic FDA data

Application 216484

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEPATCH;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
A216484-001LIDOCAINELIDOCAINE5%PATCH / TOPICALAB2025-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216484-001AB

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216484-001LIDOCAINE5%PATCH / TOPICALAB2025-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A216484-001LIDOCAINE5%PATCH / TOPICALAB2025-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216484-001LIDOCAINE5%PATCH / TOPICALAB2025-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216484-001LIDOCAINE5%PATCH / TOPICALAB2025-10-0631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216484-001LIDOCAINE5%PATCH / TOPICALAB2025-10-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216484-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A216484-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216484-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216484-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216484-001AB1a50c72e98297…

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 2 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDESentiss Pharmaceuticals LLC9b2d4f69-0c84-4956-b5c0-b4410acf62e02026-08-12Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.864e511b-cc50-4ed9-b122-8e1a934573322026-08-11Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEThe Atlanta Dental Supply Company DBA Advanced Dental Products55030c51-250b-4fc2-ba3c-ac38dab7cc8e2026-08-10Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.df130310-41db-45df-a214-9da01cf0bf412026-08-10Warnings, Adverse reactionsName fallback
brand name: Lidocaine
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL NumbingLIDOCAINEPutian Licheng District Zhijiancheng Trading Co., Ltd.4a7be9eb-5e57-90e8-e063-6394a90aad9e2026-08-08WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENDC, Inc.937e9341-e604-4ca7-98e1-fc7c659d82e92026-08-06Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
Dealmed BurnLIDOCAINEDealmed Medical Supplies, LLC.3b5f7ded-c275-4d7f-9fd4-539797d5507e2026-08-05WarningsName fallback
generic name: LIDOCAINE
Lidocaine Plantar Relief Roll-OnLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.585ccb4b-3bff-39b9-e063-6294a90a0e182026-08-05WarningsName fallback
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEPHOENIX RX LLC57edfcb8-272c-8af4-e063-6294a90ae2e52026-07-31Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dentalc5cc87df-df3f-42b8-af84-5f2045d420842026-07-30Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dental9419ac39-9b26-4cca-a2d6-167205fede242026-07-28Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLC27e8fdfb-e923-4f99-aff7-8b9e502281512026-07-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dentalf074c0dc-7c3f-46fd-a480-b8337a19fe5c2026-07-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsName fallback
generic name: LIDOCAINE
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsName fallback
generic name: LIDOCAINE
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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