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 18 of 153 · 3,057 matching rows.
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