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 58 of 157 · 3,122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
Tiger Balm Red Extra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.ce703715-4c11-472c-9270-daac87b7be052025-12-19WarningsExact identifier
unii: L7T10EIP3A
Aspercreme with Lidocaine Foot Pain CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.da82cc0e-cc39-408e-87e1-c35bb6f9f51e2025-12-19WarningsExact identifier
unii: V13007Z41A
Health Trak Plus Menthol-Infused Pain Relief SocksMENTHOLRailroad Sock LLC43413e55-1db2-fc1a-e063-6394a90a71672025-12-18WarningsExact identifier
unii: L7T10EIP3A
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPArmy & Air Force Exchange Service20ac8a20-206c-0024-e063-6394a90a9d062025-12-18WarningsExact identifier
unii: L7T10EIP3A
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPArmy & Air Force Exchange Service20ace10f-4257-b20e-e063-6394a90a3c7b2025-12-18WarningsExact identifier
unii: L7T10EIP3A
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution38560997-cfe4-2f9b-e063-6394a90a834b2025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
unii: L7T10EIP3A
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact identifier
unii: L7T10EIP3A
cherry cough dropsMENTHOLMeijer5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e2025-12-18WarningsExact identifier
unii: L7T10EIP3A
cherry cough dropsMENTHOLMeijer5bc3b9b8-e61e-1041-e053-2a91aa0a3d832025-12-18WarningsExact identifier
unii: L7T10EIP3A
BIO-ICEMENTHOL, CAMPHORElectrostim Medical Services Inc. d/b/a EMSI1bfd1468-9139-43b1-9709-d47b63d17cfb2025-12-18WarningsExact identifier
unii: L7T10EIP3A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2c33e5-290e-2f89-e063-6394a90aee692025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42caf92e-6fa9-5bd7-e063-6294a90a39042025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2bdb1f-f1c0-370d-e063-6294a90a5c502025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
honey lemon cough dropsMENTHOLMeijer5bd35bce-cd85-5314-e053-2991aa0abce62025-12-18WarningsExact identifier
unii: L7T10EIP3A
honey lemon cough dropsMENTHOLMeijer5bd42654-56e5-997e-e053-2a91aa0afd342025-12-18WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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