Home NDC 0283-1820 HurriCaine
Product NDC 0283-1820
11-digit product format 002831820
Labeler code 0283
Product ID 0283-1820_25a29681-8f39-619d-e063-6294a90a7924
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL; ORAL; PERIODONTAL
Labeler Beutlich Pharmaceuticals, LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-31
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 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 HurriCaine
Brand name suffix Topical Anesthetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238910 Internal RxNorm lookup 996288 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 0283-1820-34 HurriCaineTopical Anesthetic 4 in 1 TRAY GEL 4 4 0283-1820-43 HurriCaineTopical Anesthetic 1.5 g in 1 SYRINGE, PLASTIC GEL 1.5 4 0283-1820-27 HurriCaineTopical Anesthetic 42.52 g in 1 TUBE GEL 42.52 2 0283-1820-29 HurriCaineTopical Anesthetic 4 in 1 BOX GEL 4 2 0283-1820-44 HurriCaineTopical Anesthetic 1.2 g in 1 SYRINGE, PLASTIC GEL 1.2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0283-1820 HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20231109_fe92637a-c88a-f9dd-e053-6294a90a7fa3.zip 0283-1820 HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20241031_043bfbc3-c33a-78b7-e063-6294a90a1a5a.zip 0283-1820 HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231018_c979e958-2042-471a-bf03-e84e68620106.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 9 of 40 · 786 matching rows.
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 0283-1820-27 00283182027 42.52 g in 1 TUBE (0283-1820-27) 42.52 g 2023-08-31 No No Current 0283-1820-29 00283182029 4 SYRINGE, PLASTIC in 1 BOX (0283-1820-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-1820-44) 2023-08-01 No No Current 0283-1820-34 00283182034 4 SYRINGE, PLASTIC in 1 BOX (0283-1820-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-1820-43) 2021-01-31 0000-00-00 No No Current 0283-1820-43 00283182043 1.5 g in 1 SYRINGE, PLASTIC 1.5 g Historical 0283-1820-44 00283182044 1.2 g in 1 SYRINGE, PLASTIC 1.2 g Historical