FDA.reportPublic FDA data

Application 217221

Type
ANDA
Sponsor
DIFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEPATCH;TOPICAL1.8%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
A217221-001LIDOCAINELIDOCAINE1.8%PATCH / TOPICALAB2025-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217221-001AB

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 22:38:342026-08A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-2584e616aacf4f…
2026-08-18 06:07:402026-07A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-256a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217221-001LIDOCAINE1.8%PATCH / TOPICALAB2025-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217221-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217221-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217221-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217221-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217221-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217221-001AB1a50c72e98297…

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 10 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE PAIN RELIEVING Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2159fb73-cf6c-184a-e063-6394a90a1d142026-01-08WarningsName fallback
generic name: LIDOCAINE
Relieve A PainLIDOCAINERelieve A Pain LLCcafaa830-d894-4590-8928-d579cc791d792026-01-08WarningsName fallback
generic name: LIDOCAINE
Dr. Care Numbing CreamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47c94198-7718-bbc2-e063-6294a90a48f12026-01-07WarningsName fallback
generic name: LIDOCAINE
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsName fallback
generic name: LIDOCAINE
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcareee8cd550-64ee-432e-98e5-b68083179a3c2026-01-05WarningsName fallback
generic name: LIDOCAINE
Steady FreddyLIDOCAINEMedical Symbiosis Pty Ltdcaa9eae9-7028-5185-e053-2a95a90ac5042025-12-31WarningsName fallback
generic name: LIDOCAINE
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsName fallback
generic name: LIDOCAINE
Kroger Pain Relief Lidocaine PatchLIDOCAINEKroger Companyf6407554-c9a7-24e2-e053-2a95a90aae022025-12-30WarningsName fallback
generic name: LIDOCAINE
PAIN RELIEF PATCHESLIDOCAINELiberty Procurement, In2d381c48-402f-4e46-81b2-41a184139a612025-12-30WarningsName fallback
generic name: LIDOCAINE
PAIN RELIEF PATCHESLIDOCAINEHarris Teeter5a0501e8-bc06-4e33-8db8-93b21a7151412025-12-29WarningsName fallback
generic name: LIDOCAINE
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsName fallback
generic name: LIDOCAINE
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsName fallback
generic name: LIDOCAINE
PAIN RELIEF PATCHESLIDOCAINEAhold U.S.A., Inc,7e7a813e-424d-4a78-9c72-541c3c62606a2025-12-28WarningsName fallback
generic name: LIDOCAINE
Amazon Basics Pain Relief Patch with 4% LidocaineLIDOCAINEAmazon.com Services LLCe3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e2025-12-28WarningsName fallback
generic name: LIDOCAINE
Pain Patch Perfecto 24 Hours Lidocaine 4 % PatchLIDOCAINEPainpatchperfecto LLCa281c3e9-1c48-4905-98cc-3cedf6042adc2025-12-25WarningsName fallback
generic name: LIDOCAINE
ETADERM Numbing CreamLIDOCAINENUEPHASE LLC5292c6ff-b878-4e71-878b-4bf08207612e2025-12-24WarningsName fallback
generic name: LIDOCAINE
medlot pain relief gel patchLIDOCAINELotfancy, Inc.3ce4af20-b227-5b98-e063-6394a90ab9922025-12-23WarningsName fallback
generic name: LIDOCAINE
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu America, Inc.63911880-8194-4c7d-a72f-cab94761b2d72025-12-23WarningsName fallback
generic name: LIDOCAINE
LIDOCAINE 5%LIDOCAINEMedhome Pharma Inc46968f5a-d214-9871-e063-6394a90ab45d2025-12-22WarningsName fallback
generic name: LIDOCAINE
LidotrodeLIDOCAINEStrand Health Group1fd20b9a-b8bc-c94f-e063-6394a90a2b692025-12-18WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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