Home NDC 63824-810 Lanacane
Product NDC 63824-810
11-digit product format 638240810
Labeler code 63824
Product ID 63824-810_27093f0a-7535-4869-8ef2-82c7c8c04095
Type HUMAN OTC DRUG
Nonproprietary name Benzethonium chloride and Benzocaine
Dosage form CREAM
Route TOPICAL
Labeler RB Health (US) LLC
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-09-28
Marketing end 0000-00-00
Substance BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength 2 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63824-810-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63824-810-01 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-810 LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RB HEALTH (US) LLC] 7 Legacy NDC 20231130_96eb2dcc-4653-452a-9abd-fe92114a14ad.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-810-01 63824081001 1 TUBE in 1 CARTON (63824-810-01) > 28 g in 1 TUBE 1 tube 2012-09-28 0000-00-00 No No Current