FDA.reportPublic FDA data

Application 021380

Type
NDA
Sponsor
DENTSPLY PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XYLOCAINE DENTALLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021380-001XYLOCAINE DENTALLIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved 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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021380-001XYLOCAINE DENTAL2%INJECTABLE / INJECTIONApproved before 1982e64feba35796…

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 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDESentiss Pharmaceuticals LLC9b2d4f69-0c84-4956-b5c0-b4410acf62e02026-08-12Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-08-05Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.9c18eaf1-4a0b-4916-70b2-88a8274947112026-08-05Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC46404c7b-2ea4-e47b-e063-6294a90a779f2026-08-03Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC573a7298-b02e-230c-e063-6294a90a269c2026-07-22Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.462e9498-9eb9-456a-9022-659bcff93e3f2026-07-17Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.fa7dedcd-d78b-45f2-9dd7-f273043167d02026-07-14Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
JJ Care BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.d69ebc53-8552-449a-a973-f211328a3d3e2026-07-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Desert Harvest Releveum with LidocaineLIDOCAINE HYDROCHLORIDEDesert Harvest, Inc9ad514ab-a6bd-4564-8ba3-0149032ebf362026-07-01WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56332SUPPL2018-11-07
56267SUPPL2018-11-05