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 20 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Pain Relief LidocaineLIDOCAINEVeridian Healthcarecea6cdab-28a5-5bd0-e053-2a95a90a12952024-12-18WarningsName fallback
generic name: LIDOCAINE
Rite Aid Lidocaine Patch XLargeLIDOCAINERite Aid Corporationefa531c2-4956-e93a-e053-2995a90ae0ea2024-12-18WarningsName fallback
generic name: LIDOCAINE
Maximum Strength Pain Relief Lidocaine PatchLIDOCAINERite Aid Corporationbd31105a-f73f-2f57-e053-2995a90a59c02024-12-18WarningsName fallback
generic name: LIDOCAINE
Meijer Lidocaine Pain Relief Patch Assortment MediumLIDOCAINEMeijer Distribution Incab83b445-0e11-b985-e053-2995a90a02782024-12-18WarningsName fallback
generic name: LIDOCAINE
Meijer Lidocaine Pain Relief Patch Assortment LargeLIDOCAINEMeijer Distribution Incaa7f9bc8-0d56-5dde-e053-2a95a90af0e72024-12-18WarningsName fallback
generic name: LIDOCAINE
Meijer Lidocaine Pain Relief Patch Assortment SmallLIDOCAINEMeijer Distribution Incab85ce5a-8787-4317-e053-2a95a90a62bc2024-12-18WarningsName fallback
generic name: LIDOCAINE
MEIJER LIDOCAINE PAIN RELIEF BACK AND LARGE AREASLIDOCAINEMeijer Distribution Incb9e512e3-8337-1f44-e053-2a95a90a7fcb2024-12-18WarningsName fallback
generic name: LIDOCAINE
HealthWise Lidocaine Pain reliefLIDOCAINEVeridian Healthcarece28a1d0-49f1-ed6f-e053-2a95a90a50db2024-12-18WarningsName fallback
generic name: LIDOCAINE
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incf591588e-467b-4c37-b0e1-c0be844220412024-12-18WarningsName fallback
generic name: LIDOCAINE
TheraCare Pain Relieving Patch with LidocaineLIDOCAINEVeridian Healthcaref93b00e1-06d6-9066-e053-6294a90ae89a2024-12-18WarningsName fallback
generic name: LIDOCAINE
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incaa5da66d-3ba9-4120-be35-44bec475761a2024-12-18WarningsName fallback
generic name: LIDOCAINE
THERA CARE PAIN THERAPYLIDOCAINEVeridian Healthcaree023bb5a-a4bc-4681-a1f4-48ca0d2cb1022024-12-18WarningsName fallback
generic name: LIDOCAINE
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFEf2ef9c12-6e42-486b-b6f2-0ad534e942942024-12-18WarningsName fallback
generic name: LIDOCAINE
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFE05a9605b-0d01-4333-8e54-7202e7c31c492024-12-18WarningsName fallback
generic name: LIDOCAINE
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsName fallback
generic name: LIDOCAINE
Albertsons Pain Relief PatchLIDOCAINESafewaydc2823bb-8586-daca-e053-2995a90a2af02024-12-17WarningsName fallback
generic name: LIDOCAINE
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company204b96bc-af4e-4842-8b57-7b416feb4dd92024-12-17WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEQuality Care Products LLCf20ab860-e49a-4f3f-868e-6a60780af5a72024-12-16Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Lidocaine DryLIDOCAINECVSbb7955fe-5113-1662-e053-2a95a90a85a12024-12-16WarningsName fallback
generic name: LIDOCAINE
Natural Seal Itch Relief for KidsLIDOCAINEKericure Inc.31cc0c95-5864-4737-b085-8f58e00f4f052024-12-12WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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