Home NDC 0283-1016 HurriCaine
Product NDC 0283-1016
11-digit product format 002831016
Labeler code 0283
Product ID 0283-1016_259039d7-ae05-7abc-e063-6294a90af1fd
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 2016-10-15
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 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0283-1016-00 HurriCaineTopical Anesthetic 28.4 g in 1 BOTTLE, PLASTIC GEL 28.4 45 0283-1016-31 HurriCaineTopical Anesthetic 1 in 1 BOX GEL 1 45 0283-1016-43 HurriCaineTopical Anesthetic 1 g in 1 PACKET GEL 1 45 0283-1016-45 HurriCaineTopical Anesthetic 0.5 g in 1 CUP, UNIT-DOSE GEL 0.5 6 0283-1016-59 HurriCaineTopical Anesthetic 60 in 1 BOX GEL 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0283-1016 HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC] 45 Current NDC, Legacy NDC, 3 package rows 20250110_42521b29-67e4-4a16-848d-7e6ba4a7ece2.zip 0283-1016 HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241030_0605d5d6-82bd-415e-b5cb-e273f934a4a7.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 0283-1016-00 00283101600 28.4 g in 1 BOTTLE, PLASTIC 28.4 g Historical 0283-1016-31 00283101631 1 BOTTLE, PLASTIC in 1 BOX (0283-1016-31) / 28.4 g in 1 BOTTLE, PLASTIC (0283-1016-00) 2016-10-15 0000-00-00 No No Current 0283-1016-43 00283101643 1 g in 1 PACKET (0283-1016-43) 1 g 2020-01-28 0000-00-00 No No Current 0283-1016-45 00283101645 0.5 g in 1 CUP, UNIT-DOSE 0.5 g Historical 0283-1016-59 00283101659 60 CUP, UNIT-DOSE in 1 BOX (0283-1016-59) / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45) 2021-01-31 0000-00-00 No No Current