Home NDC 46122-614 GNP Lidocaine
Product NDC 46122-614
11-digit product format 461220614
Labeler code 46122
Product ID 46122-614_5569a6ca-269c-c535-e063-6394a90aaf7f
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCl
Dosage form CREAM
Route TOPICAL
Labeler AMERISOURCE BERGEN
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-24
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100g
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 46122-614-10 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 46122-614-10 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 46122-614-10 bd6a592717d7…303034d00443…
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 GNP Lidocaine
Brand name suffix Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g
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 1010895 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46122-614-10 GNP LidocaineMaximum Strength 1 in 1 CARTON CREAM 1 5 46122-614-10 GNP LidocaineMaximum Strength 76.5 g in 1 BOTTLE, PLASTIC CREAM 76.5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-614 GNP LIDOCAINE MAXIMUM STRENGTH (LIDOCAINE HCL) CREAM [AMERISOURCE BERGEN] 4 Current NDC, Legacy NDC, 2 package rows 20241225_9f559c20-c9ac-e480-e053-2a95a90a8fce.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 77 of 152 · 3,029 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 46122-614-10 46122061410 1 BOTTLE, PLASTIC in 1 CARTON (46122-614-10) / 76.5 g in 1 BOTTLE, PLASTIC 2020-02-24 0000-00-00 No No Current