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 65 of 156 · 3,112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basic Care Cherry Cough DropsMENTHOLAmazon.comc0588221-0c84-66d8-e053-2995a90a874f2025-12-05WarningsExact identifier
unii: L7T10EIP3A
Basic Care Honey Lemon Cough DropsMENTHOLAmazon.comc0937b13-f679-a764-e053-2a95a90abf892025-12-05WarningsExact identifier
unii: L7T10EIP3A
Basic Care SF Menthol Cough DropsMENTHOLAmazon.comc0946295-7cf0-1bd8-e053-2a95a90af5af2025-12-05WarningsExact identifier
unii: L7T10EIP3A
Basic Care SF Honey Lemon Cough DropsMENTHOLAmazon.comcf82fb0b-1b4d-def1-e053-2995a90a6fd92025-12-05WarningsExact identifier
unii: L7T10EIP3A
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
unii: V13007Z41A
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
unii: L7T10EIP3A
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
unii: L7T10EIP3A
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
unii: V13007Z41A
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
unii: L7T10EIP3A
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
unii: L7T10EIP3A
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
unii: L7T10EIP3A
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
unii: V13007Z41A
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
unii: L7T10EIP3A
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
unii: L7T10EIP3A
Leader LidocaineLIDOCAINE HCLCARDINAL HEALTHcece6765-0e2f-5ce9-e053-2995a90a37582025-12-03WarningsExact identifier
unii: V13007Z41A
Westlake LidocaineLIDOCAINE HCLWestlake Pharma LLC0c586a14-1a2a-9f42-e063-6294a90a16c12025-12-03WarningsExact identifier
unii: V13007Z41A
CVS Lidocaine Maximum StrengthLIDOCAINE HCLCVS Pharmacy87490c0f-a4d9-740e-e053-2a95a90a47242025-12-03WarningsExact identifier
unii: V13007Z41A
CVS Maximum Strength BurnLIDOCAINE HYDROCHLORIDE 4%CVS Pharmacy4510f379-c5a4-92c3-e063-6294a90a0a322025-12-03WarningsExact identifier
unii: V13007Z41A
LidoPatch Pain ReliefLIDOCAINE, MENTHOLJAR Laboratories07289aa1-43ed-df31-e063-6394a90a764a2025-12-03WarningsExact identifier
unii: L7T10EIP3A
Equate Pain Relief Cream4% LIDOCAINE HCLWalmart, Inc7d8e8a9a-5474-4c7b-e053-2991aa0a29f52025-12-03WarningsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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