Home NDC 0283-0610 HurriCaine
Product NDC 0283-0610
11-digit product format 002830610
Labeler code 0283
Product ID 0283-0610_5c90e595-a2ce-1246-e063-6294a90a0d5c
Type HUMAN OTC DRUG
Nonproprietary name Topical Anesthetic
Dosage form SPRAY
Route DENTAL; PERIODONTAL
Labeler Beutlich Pharmaceuticals LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-06-15
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 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 HurriCaine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0283-0610-11 HurriCaine 2 in 1 BOX SPRAY 2 29 0283-0610-26 HurriCaine 25 in 1 BOX SPRAY 25 29 0283-0610-43 HurriCaine 0.492 g in 1 APPLICATOR SPRAY 0.492 29
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0283-0610 HURRICAINE (TOPICAL ANESTHETIC) SPRAY [BEUTLICH PHARMACEUTICALS LLC] 27 Current NDC, Legacy NDC, 3 package rows 20240208_255fba91-6357-4414-ad23-a18694ef886b.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 29 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 0283-0610-11 00283061011 2 APPLICATOR in 1 BOX (0283-0610-11) / .492 g in 1 APPLICATOR (0283-0610-43) 2 applicator 2016-04-01 0000-00-00 No No Current 0283-0610-26 00283061026 25 APPLICATOR in 1 BOX (0283-0610-26) / .492 g in 1 APPLICATOR (0283-0610-43) 25 applicator 2016-04-01 0000-00-00 No No Current 0283-0610-43 00283061043 0.492 g in 1 APPLICATOR 0.492 g Historical