FDA.reportPublic FDA data

Application 014394

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XYLOCAINELIDOCAINEAEROSOL;ORAL10%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
N014394-001XYLOCAINELIDOCAINE10%AEROSOL / ORALApproved before 1982

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N014394-001XYLOCAINE10%AEROSOL / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014394-001XYLOCAINE10%AEROSOL / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N014394-001XYLOCAINE10%AEROSOL / ORALApproved before 1982a50c72e98297…

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 1 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsName fallback
generic name: LIDOCAINE
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsName fallback
generic name: LIDOCAINE
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINEREMEDYREPACK INC.dfef4554-aeb4-4bdf-9557-648d3e84af3c2026-08-31Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEA-S Medication Solutions3fbe48b5-128a-471c-8ecb-45e903b567402026-08-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEREMEDYREPACK INC.1414bcfc-1543-4ad4-83bd-4fc444a02e922026-08-27Warnings, Adverse reactionsName fallback
brand name: Xylocaine
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINESt. Mary's Medical Park Pharmacy9dc3059c-3a3d-5810-e053-2a95a90ab0ba2026-08-26Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsName fallback
generic name: LIDOCAINE
Foot Pain Relief PadsLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.5a18ff72-8a3e-5cdb-e063-6394a90a61622026-08-25WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Big Toe Joint Pain Relief PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8ff98-55c7-796d-e063-6394a90af73a2026-08-24WarningsName fallback
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsName fallback
generic name: LIDOCAINE
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsName fallback
generic name: LIDOCAINE
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical14b55cf9-f7cd-4bb4-a7c5-aba61abadef12026-08-13Warnings, Adverse reactionsName fallback
brand name: Xylocaine

Reported adverse events (FAERS/openFDA)#

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