Home NDC 61010-5100 Lidocaine Hydrochloride
Product NDC 61010-5100
11-digit product format 610105100
Labeler code 61010
Product ID 61010-5100_114b1a82-0728-fe2e-e063-6394a90a309e
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form LIQUID
Route TOPICAL
Labeler Safetec of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-08-02
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 61010-5100 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61010-5100 61010-5100-3 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010769 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61010-5100-3 2024-02-13 61010-5100, Burn Spray 61010-5100-4 2024-02-13 61010-5100, Burn Spray 61010-5100-5 2024-02-13 61010-5100, Burn Spray 61010-5100-3 2024-01-30 61010-5100, Burn Spray 61010-5100-4 2024-01-30 61010-5100, Burn Spray 61010-5100-5 2024-01-30 61010-5100, Burn Spray 61010-5100-3 2020-03-10 61010-5100, Burn Spray 61010-5100-3 2020-01-31 61010-5100, Burn Spray
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5100-4 Lidocaine Hydrochloride 59.1 mL in 1 BOTTLE, SPRAY LIQUID 59.1 7 61010-5100-5 Lidocaine Hydrochloride 118 mL in 1 BOTTLE, SPRAY LIQUID 118 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5100 LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240214_8eb3e7e2-26e5-430e-89aa-40a0367c637e.zip
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 116 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hempvana Cold As Ice Pain Relief Gel-Patch MENTHOL Telebrands Corp 976a1bb2-b776-8199-e053-2995a90a1a1b 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief TROLAMINE SALICYLATE TELEBRANDS CORP d91a0fad-a38c-1580-e053-2a95a90ad268 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief - Platinum TROLAMINE SALICYLATE TELEBRANDS CORP d58da6c5-47a6-b8a8-e053-2995a90a7ce7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP df5d3312-cbc5-5db9-e053-2995a90ab055 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold as Ice Gel MENTHOL Telebrands Corp a9e103f2-778f-e49b-e053-2a95a90aa8b7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP d58e2c47-c0f4-625e-e053-2a95a90aa4d5 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Pain Relief TROLAMINE SALICYLATE Telebrands Corp 92a29553-a102-0a0e-e053-2a95a90ab24a 2024-11-20 Warnings Exact identifier application number: M017 Ultra Strength Pain Relief Gel MENTHOL TELEBRANDS CORP d91b2e09-550e-4968-e053-2995a90ae323 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream LIDOCAINE 4% Telebrands Corp c3162ba8-ac2d-5a65-e053-2995a90af246 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief LIDOCAINE TELEBRANDS CORP d91ba9b1-083f-32e9-e053-2a95a90a9bd1 2024-11-20 Warnings Exact identifier application number: M017 DynaRub PAIN RELIEVING CREAM Dynarex Corporation 7f853941-a2d7-ed26-e053-2991aa0aa9ee 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions bcdc0322-bc75-4662-9c5a-d1be1d055252 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 604a30c9-2306-47a1-bd31-94b63639dd90 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 0b489420-3b5c-43c5-aab4-0e3720acf9ce 2024-11-20 Warnings Exact identifier application number: M017 MYCO Clinic Pain Relief CAMPHOR, MENTHOL Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions dd906129-a787-4352-856d-d7a915031a6e 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Arthritis Pain Relief Cream HISTAMINE DIHYDROCHLORIDE Walgreens Company 80d3031a-7fa9-4f5b-b85e-c7c6ef314801 2024-11-20 Warnings Exact identifier application number: M017 Anti-Itch Medicated Maximum Strength BENZOCAINE AND RESORCINOL Walgreens Company 7fd86dcb-edef-4d0d-b389-7ecea595fe67 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Pain Relief BENZOCAINE Walgreens Company 7cee7234-32cd-4bf3-8a6c-0882585eec7f 2024-11-20 Warnings Exact identifier application number: M017 Walgreens Advanced Scar Gel ADVANCED SCAR GEL Walgreens Company 2c040475-a124-485c-933e-66b452f5ab46 2024-11-20 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Clinic Pharma 274611ea-7fc2-ba3f-e063-6294a90aa50f 2024-11-19 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61010-5100-4 61010510004 59.1 mL in 1 BOTTLE, SPRAY (61010-5100-4) 59.1 ml 2011-08-02 0000-00-00 No No Current 61010-5100-5 61010510005 118 mL in 1 BOTTLE, SPRAY (61010-5100-5) 118 ml 2011-08-02 0000-00-00 No No Current