FDA.reportPublic FDA data

Application 088331

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%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
A088331-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-1784e616aacf4f…
2026-08-18 06:07:402026-07A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-173f01610625f2…
2019-09-15 20:21 UTC2019-09A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088331-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION1984-05-17f41ea6bd6efb…

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 4 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.cf723c7b-495d-4bae-942c-561cf28af2d32026-02-21WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDEBaxter Healthcare Corporationf21512ea-c7c3-4766-b976-b2c0b5616bf02026-02-20Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAdvagen Pharma Ltdae40021b-8df8-4b16-aac0-dcec88f76c7d2026-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAnthea Pharma Private Limited240c4744-e58c-4c08-93ad-8d6418c4f8a92026-02-11Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC89701fac-7536-4f16-87fb-f4cc121e74ee2026-02-11Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.2b58058a-f350-4029-b039-117caf1c03732026-02-05WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
glydoLIDOCAINE HYDROCHLORIDESagent Pharmaceuticals65760723-75cd-472c-96e1-7d05f95b46862026-02-04Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESportpharm LLC415a29c1-101a-4ac2-9ba9-b419a1ce56002026-02-03Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
XylocaineLIDOCAINE HYDROCHLORIDESportpharm LLC94155012-b1fc-430a-a1f5-30c21f4a3f802026-02-03Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
5Kind Maximum Strength Pain Relieving Lidocaine HCl HempLIDOCAINE HYDROCHLORIDE5Kind Trading LTDc2df4c90-2b9e-460a-8f54-5d824b4841632026-01-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
VonaFlex Effective Pain Relief Topical AnalgesicLIDOCAINE HYDROCHLORIDEOPTIMAL LABORATORIES, LLC0901244a-7d41-413a-b424-92a807532f282026-01-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
ALOE ICE SUNBURN RELIEFLIDOCAINE HYDROCHLORIDEAloe Care International, LLC56866fa8-052e-497c-a954-978d7d6289492026-01-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEChartwell RX, LLCc05f49a2-7512-48e7-9730-f8ee05519b9d2026-01-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.f79b8b30-67ed-4daa-8233-ee2319592ef02026-01-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution48c18a90-9d53-d200-e063-6394a90a12712026-01-19Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
CVS Lidocaine Pain Relief CreamLIDOCAINE HYDROCHLORIDECVS Pharmacy45c4f946-13b9-7a0a-e063-6394a90a73532026-01-16WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEChattem, Inc.5767362c-83af-494e-a815-a13f2cb093ef2026-01-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine Foot (Diabetic)LIDOCAINE HYDROCHLORIDEChattem, Inc.2c33d15e-5032-46d9-bd98-5abc7df3bbe52026-01-13WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAvenacy, LLC46480253-29b9-4d7f-98ed-10377929026b2026-01-13Warnings, Adverse reactionsName fallback
brand name: lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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