Home NDC 79974-216 Mamisan
Product NDC 79974-216
11-digit product format 799740216
Labeler code 79974
Product ID 79974-216_e4a7ecde-0c1a-43da-8488-1f31b106c2dc
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride, Menthol
Dosage form OINTMENT
Route TOPICAL
Labeler Miramar Cosmetics, Inc DBA Miramar Lab
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-02
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 4; 1 g/100g; 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 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 Mamisan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g MENTHOL, UNSPECIFIED FORM 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2471955 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79974-216-03 Mamisan 100 g in 1 JAR OINTMENT 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79974-216 MAMISAN (LIDOCAINE HYDROCHLORIDE, MENTHOL) OINTMENT [MIRAMAR COSMETICS, INC DBA MIRAMAR LAB] 1 Current NDC, 1 package rows 20240903_4402e900-c6e9-4f32-8cc4-c84014384a9f.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 Sample Exclude flag Status 79974-216-03 79974021603 100 g in 1 JAR (79974-216-03) 100 g 2024-09-02 No No Current