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 6 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0897cc86-c775-8821-e063-6394a90a6fcf2026-05-14WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain Relief Gel -PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4bdec2ee-37ee-86ea-e063-6294a90a49fd2026-05-14WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.2d76dd9a-6291-ae75-e063-6394a90a30e62026-05-14WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.31a099c4-91d8-352a-e063-6394a90a035f2026-05-14WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsName fallback
generic name: LIDOCAINE
Stud 100 Male Genital DesensitizerLIDOCAINEPound International Corpd075656e-b13f-4a1d-bbb6-501e642698d52026-05-12WarningsName fallback
generic name: LIDOCAINE
BonicaEaseX Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7486fe89-a377-4a37-997d-e3bd16b891a72026-05-11WarningsName fallback
generic name: LIDOCAINE
Walmart Equate Aloe Sunburn Relief CoolingLIDOCAINEWAL-MART STORES INC.51540f6b-596f-bc47-e063-6294a90a46ae2026-05-08WarningsName fallback
generic name: LIDOCAINE
Lidocaine 4% CreamLIDOCAINEMedcore LLC111cb421-ba3b-4772-ab60-d31eb41831682026-05-07WarningsName fallback
generic name: LIDOCAINE
Lidocaine 5% CreamLIDOCAINEMedcore LLC15d02b42-bf8b-486a-a081-f6d17cc11ec72026-05-07WarningsName fallback
generic name: LIDOCAINE
LidoxiLIDOCAINET&T Pharma Holdings LLC513c517e-c098-02aa-e063-6294a90ac8a42026-05-07WarningsName fallback
generic name: LIDOCAINE
TheraCare Flexible Pain RelievingLIDOCAINEVeridian Healthcare4f108002-2cae-0671-e063-6294a90ab6cf2026-04-30WarningsName fallback
generic name: LIDOCAINE
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsName fallback
generic name: LIDOCAINE
Dr. NumbLIDOCAINEShinpharma Inc32ab24b4-dcec-4a09-e054-00144ff88e882026-04-30WarningsName fallback
generic name: LIDOCAINE
Dr. NumbLIDOCAINEShinpharma Incc2c0cb17-401a-4ba2-aa04-64c9b43cd21b2026-04-30WarningsName fallback
generic name: LIDOCAINE
Dr. NumbLIDOCAINEShinpharma Ince840fba4-86ff-9da0-e053-2995a90a221a2026-04-30WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLCcffda6fc-7e85-4c48-9623-2551d3552d7d2026-04-24Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.1ca96c77-d983-496b-84a6-54709e80f5322026-04-23Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.f8d90500-f797-4238-8dd2-b59cbcd89d122026-04-23Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLC7adb9ab0-ef91-4c51-baa3-a0b7e12df0772026-04-21Warnings, Adverse reactionsName fallback
brand name: Lidocaine

Reported adverse events (FAERS/openFDA)#

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