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 11 of 158 · 3,158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
unii: L7T10EIP3A
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
unii: L7T10EIP3A
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
unii: L7T10EIP3A
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
unii: L7T10EIP3A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
unii: V13007Z41A
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
unii: L7T10EIP3A
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
unii: L7T10EIP3A
Nervionix Pro Magnesium IceLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporatedc11e0963-90fb-48c6-938a-3dcbbad17aca2026-07-09WarningsExact identifier
unii: L7T10EIP3A
unii: V13007Z41A
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
unii: ZY81Z83H0X
LidexaGel 5%LIDOCAINE HCLOncora Pharma, LLCb45a7d2f-111f-4390-9b90-570b1c9f5ffc2026-07-08Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
unii: L7T10EIP3A
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow Balm Roll On Pain ReliefMENTHOLWB Ventures LLC3b1834e6-75cd-5380-e063-6294a90ad1d52026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow Balm Itch Relief CreamMENTHOLWB Ventures LLC0ce31b5d-4401-460c-e063-6394a90ab5582026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow BalmMENTHOLWB VENTURES LLCb9f50c43-b0d5-39a8-e053-2995a90a04f12026-07-08WarningsExact identifier
unii: L7T10EIP3A
Natures Willow Bug Bite BalmMENTHOLWB Ventures LLCb9fab18f-32c7-d5bd-e053-2995a90a6d0f2026-07-08WarningsExact identifier
unii: L7T10EIP3A
Salonpas pain relieving hotCAPSAICIN, MENTHOLHisamitsu Pharmaceutical Co., Inc.d2aa8820-a947-404b-b617-e692fbd165022026-07-07WarningsExact identifier
unii: L7T10EIP3A
CrysaloMETHYL SALICYLATE, MENTHOLV2 Pharma, LLCd6c475f0-1098-41cd-868a-a5e528a5e5ae2026-07-06WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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