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 3 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsName fallback
generic name: LIDOCAINE
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsName fallback
generic name: LIDOCAINE
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsName fallback
generic name: LIDOCAINE
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEShaanxi Shuvita Biotech Co., Ltd572b95a1-11b2-6328-e063-6394a90acb732026-07-21WarningsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsName fallback
generic name: LIDOCAINE
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsName fallback
generic name: LIDOCAINE
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEA-S Medication Solutions2bb5b298-3802-446c-b8cd-313e84bff04e2026-07-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEASCLEMED USA INC.56a54ef4-7aa0-e181-e063-6394a90a3e0e2026-07-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain Relief Gel -PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.51d32d7c-3ba7-81cd-e063-6294a90a20412026-07-14WarningsName fallback
generic name: LIDOCAINE
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDICAINEEncube Ethicals, Inc.e9f80c8a-05ba-47f8-aff1-e2583b2f8e572026-07-03Warnings, Adverse reactionsName fallback
brand name: Lidocaine
Burn ReliefLIDOCAINEAmerisourceBergen Drug Corporation7d898e33-ded7-c9b9-e053-2a91aa0adf7c2026-07-01WarningsName fallback
generic name: LIDOCAINE
Desert Harvest RELEVEUMLIDOCAINEDesert Harvest Inc.5d9010ec-d482-44ff-ba27-3bfec5a241c62026-06-30WarningsName fallback
generic name: LIDOCAINE
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.556028b3-06f7-0720-e063-6294a90a2df82026-06-29WarningsName fallback
generic name: LIDOCAINE
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsName fallback
generic name: LIDOCAINE
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsName fallback
generic name: LIDOCAINE
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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