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 4 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEGolden State Medical Supply, Inc.0bef12dd-6cea-d12b-e063-6394a90a002e2026-06-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsName fallback
generic name: LIDOCAINE
Tridacaine IILIDOCAINETrifluent Pharma LLC1e940ba6-3916-4fc4-8886-481fc9685fc12026-06-12Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
lidocaineLIDOCAINEREMEDYREPACK INC.2cc3d25d-cefd-448d-beec-ac602c2110fd2026-06-11Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
lidocaineLIDOCAINEREMEDYREPACK INC.499b4443-7aed-4ac5-ab16-f47e759c32012026-06-10Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
Lidocaine 4 PercentLIDOCAINEPreferred Pharmaceuticals Inc.ce379d77-bba4-4f8c-a42c-27ce06aa38a52026-06-09WarningsName fallback
generic name: LIDOCAINE
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsName fallback
generic name: LIDOCAINE
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsName fallback
generic name: LIDOCAINE
lidocaineLIDOCAINENorthstar Rx LLCcde68b0c-a1ee-421d-9ca8-bc571d2990ab2026-06-08Warnings, Adverse reactionsName fallback
brand name: lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEREMEDYREPACK INC.9bf01533-ed83-4440-bdc4-4b45729bfc312026-06-05Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINESun Pharmaceutical Industries, Inc.5eb2c62f-5352-41d7-bd66-c65b1988a9ab2026-06-03Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsName fallback
generic name: LIDOCAINE
Healcome Lidocaine Numbing CreamLIDOCAINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD9b4eac02-1b1f-4630-92b4-b1d8c21abab52026-05-29WarningsName fallback
generic name: LIDOCAINE
Aspercreme Lidocaine XLLIDOCAINELead Chemical Co., Ltd.b1077b76-7ae7-4b1b-a972-c1b10e9671f92026-05-29WarningsName fallback
generic name: LIDOCAINE
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsName fallback
generic name: LIDOCAINE
MyDerm Medical 5 Lidocaine Numbing Roll-OnLIDOCAINEInspec Solutions1d466be1-a780-462f-8dd4-87478da096aa2026-05-27WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEPar Health USA, LLC2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc2026-05-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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