Home NDC 55346-2902 Alpha-Caine
Product NDC 55346-2902
11-digit product format 553462902
Labeler code 55346
Product ID 55346-2902_42c88c25-44d7-ec17-e063-6294a90addbe
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL; PERIODONTAL
Labeler Dental Technologies, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 1999-12-31
Substance BENZOCAINE
Active strength 200 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 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only
warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy
Additional Listing Data#
Finished product Yes
Brand name base Alpha-Caine
Brand name suffix Topical Anesthetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii U3RSY48JW5 Rxcui 238910, 1297832
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55346-2902-1 Alpha-CaineTopical Anesthetic 30 g in 1 BOTTLE, PLASTIC GEL 30 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55346-2902 ALPHA-CAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [DENTAL TECHNOLOGIES, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20231216_ae628766-25b7-4b4f-abb8-a43faf2f44b9.zip
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 55346-2902-1 55346290201 30 g in 1 BOTTLE, PLASTIC (55346-2902-1) 30 g 1999-12-31 0000-00-00 No No Current