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 15 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Pain Relief Gel Roll-OnLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd31639407-0f11-bde2-e063-6294a90af6942025-08-10WarningsName fallback
generic name: LIDOCAINE
Chinese Red Tiger Lidocaine PatchesLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd20cd369c-3e98-3d8f-e063-6394a90a08242025-08-10WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEBryant Ranch Prepack015cea25-d323-43dd-a92f-593a8e4a29212025-08-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
lidocaine pain relief patchesLIDOCAINEChangsha Maocheng Trading Co., Ltd3afeead3-4f5c-4711-e063-6294a90aacca2025-07-28WarningsName fallback
generic name: LIDOCAINE
AIPATCH NUMBING PAIN RELIEFLIDOCAINEActive Intelligence, LLC56f27540-9b2a-4266-9e15-a5b2d738c7a12025-07-25WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEAdvanced Rx of Tennessee, LLC3a9a6630-e470-b794-e063-6394a90aaab52025-07-23Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Arthcal 4% Lidocaine PatchesLIDOCAINEBeijing JUNGE Technology Co., Ltd.2e531194-67ad-c645-e063-6394a90a916c2025-07-22WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINEPHOENIX RX LLC3a63652c-92a1-612b-e063-6294a90a034a2025-07-21Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
generic name: LIDOCAINE
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEGolden State Medical Supply, Inc.b948d6fe-3893-39a1-e053-2995a90ae64c2025-07-11Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
INVIGOR OHLIDOCAINENatureplex LLC7c7b536d-e41a-4017-9df9-982e2e9cfe4e2025-07-10WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsName fallback
brand name: LIDOCAINE
LidocaineLIDOCAINESun Pharmaceutical Industries, Inc.ae758020-a508-4a2e-8164-e6c324e826a32025-07-02Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Syntherma PlusLIDOCAINEV2 Pharma, LLC1a312322-9c4a-4f14-be7f-05ccad1601bf2025-07-01Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsName fallback
generic name: LIDOCAINE
Orythia Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d658d495-dd2c-40b7-9446-6f10040ed55e2025-06-27WarningsName fallback
generic name: LIDOCAINE
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd3875bde5-2e1a-5fdf-e063-6294a90a3c0d2025-06-26WarningsName fallback
generic name: LIDOCAINE
MedlineLIDOCAINEMedline Industries, LP0d6d0d4e-60d5-74b2-e063-6294a90a2da62025-06-26WarningsName fallback
generic name: LIDOCAINE
Hilook Blue Gel AnestheticLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9db681-a297-5aa9-e063-6394a90a80ea2025-06-25WarningsName fallback
generic name: LIDOCAINE
Hilook Numbing CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9f1a4c-ca0b-d820-e063-6394a90a32392025-06-25WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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