FDA.reportPublic FDA data

NDC 0924-5000-00 - Lidocaine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0924-5000
Requested NDC
0924-5000-00
Package NDCs from labels
0924-5000-00, 0924-5000-01, 0924-5000-02
Manufacturer
Acme United Corporation | Safetec of America, Inc.
Effective date
2016-03-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Burn Gel Pain ReliefAcme United Corporation | Safetec of America, Inc.2016-03-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0924-5000-012021-01-29C16284748780-1ba0f9c33-5e38-a910-e053-dadaa90a0b85Burn Gel Pain Relief
0924-5000-022021-01-29C16284748780-1ba0f9c33-5e38-a910-e053-dadaa90a0b85Burn Gel Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5000-00Lidocaine Hydrochloride3.5 g in 1 PACKETGEL3.53
0924-5000-01Lidocaine Hydrochloride6 in 1 BOXGEL63
0924-5000-02Lidocaine Hydrochloride25 in 1 BOXGEL253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5000LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]3Legacy NDC, 3 package rows20191231_c20f9d77-2572-4050-8b8c-8337ca67124e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
mentholINACTIVE INGREDIENTL7T10EIP3ALIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
trolamineINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE GEL [ACME UNITED CORPORATION]1

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 35 of 157 · 3,137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.5cb2eabe-46f2-48c0-9a4c-6518513ed34f2026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.be116a1c-697a-451b-aa2e-d39bdc2f6ff82026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreen Co.0780b123-a401-405b-9e50-6be818d71d392026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: L7T10EIP3A
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
rxcui: 1011852
unii: V13007Z41A
LMNOOPMENTHOLShenzhen iShan Technology Co., Ltdd0f718e4-91dd-51d2-e053-2a95a90ae44f2026-02-12WarningsExact identifier
unii: L7T10EIP3A
PETROLATUMISHANCARE HEMORRHOID CREAMShenzhen Ishan Technology Co., Ltdd22536d0-b935-6a20-e053-2a95a90af3ed2026-02-12WarningsExact identifier
unii: L7T10EIP3A
iShanCare PAIN RELIEF Gel-PatchMENTHOLShenzhen Ishan Technology Co., Ltd29b5c3c2-b9d5-5198-e063-6294a90ab7a42026-02-12WarningsExact identifier
unii: L7T10EIP3A
iShanCare PAIN RELIEF Gel-PatchLIDOCARINE AND MENTHOLShenzhen Ishan Technology Co., Ltd29b36a93-438e-efd9-e063-6394a90a037a2026-02-12WarningsExact identifier
unii: L7T10EIP3A
iShanCare PAIN RELIEF Gel-PatchLIDOCARINEShenzhen Ishan Technology Co., Ltd29739289-42b6-0047-e063-6394a90ad9312026-02-12WarningsExact identifier
unii: L7T10EIP3A
Yimimde PAIN RELIEF Gel-PatchLIDOCARINE AND MENTHOLShenzhen Ishan Technology Co., Ltd29b4fc6d-a588-c1a4-e063-6394a90ae9dd2026-02-12WarningsExact identifier
unii: L7T10EIP3A
Ice Gel ICE COLD ANALGESICMENTHOLJell Pharmaceuticals Pvt Ltd4a8b3f84-8c45-eb94-e063-6394a90a3e732026-02-11WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E B21364d47-d026-4b48-8ece-ac44717f65222026-02-11Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E B8ba4382d-1a88-4a8d-9d40-c0f38cfd01a52026-02-11Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAnthea Pharma Private Limited240c4744-e58c-4c08-93ad-8d6418c4f8a92026-02-11Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC89701fac-7536-4f16-87fb-f4cc121e74ee2026-02-11Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF4a7f92d3-dd35-44a3-e063-6294a90ae0042026-02-10WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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