Home NDC 83037-041 DZUL - LIDO CREME
Product NDC 83037-041
11-digit product format 830370041
Labeler code 83037
Product ID 83037-041_47e61d24-653c-15d0-e063-6294a90a9312
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HCL, MENTHOL
Dosage form LOTION
Route TOPICAL
Labeler Caball Sales, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-17
Substance MENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength 1; 4 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 DZUL - LIDO CREME
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1 g/100g LIDOCAINE HYDROCHLORIDE 4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 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 2598162 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 83037-041-02 DZUL - LIDO CREME 71 g in 1 BOTTLE, WITH APPLICATOR LOTION 71 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83037-041 DZUL - LIDO CREME (LIDOCAINE HCL, MENTHOL) LOTION [CABALL SALES, INC.] 1 Current NDC, 1 package rows 20231004_063387e4-a1b1-a467-e063-6294a90a6cbd.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 83037-041-02 83037004102 71 g in 1 BOTTLE, WITH APPLICATOR (83037-041-02) 71 g 2023-10-02 No No Current