Home NDC 0283-1116 HurriCaine
Product NDC 0283-1116
11-digit product format 002831116
Labeler code 0283
Product ID 0283-1116_2b382c02-1311-a447-e063-6394a90ac5c1
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form LIQUID
Route DENTAL; ORAL; PERIODONTAL
Labeler Beutlich Pharmaceuticals, LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-15
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 Liquid
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 308657 Internal RxNorm lookup 808062 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 0283-1116-00 HurriCaineTopical Anesthetic Liquid 29.6 g in 1 BOTTLE, PLASTIC LIQUID 29.6 25 0283-1116-31 HurriCaineTopical Anesthetic Liquid 1 in 1 BOX LIQUID 1 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0283-1116 HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC] 25 Current NDC, Legacy NDC, 2 package rows 20250110_31232583-180c-43d1-bc45-c3f6d9ea5081.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 0283-1116-00 00283111600 29.6 g in 1 BOTTLE, PLASTIC 29.6 g Historical 0283-1116-31 00283111631 1 BOTTLE, PLASTIC in 1 BOX (0283-1116-31) > 29.6 g in 1 BOTTLE, PLASTIC (0283-1116-00) 2016-11-15 0000-00-00 No No Current