FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0283-18200283-1820-34DDiscontinued by firm2026-10-16

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
IngredientStrength
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238910Internal RxNorm lookup
996288Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
043bfbc3-c33a-78b7-e063-6294a90a1a5aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-1820-34HurriCaineTopical Anesthetic4 in 1 TRAYGEL44
0283-1820-43HurriCaineTopical Anesthetic1.5 g in 1 SYRINGE, PLASTICGEL1.54
0283-1820-27HurriCaineTopical Anesthetic42.52 g in 1 TUBEGEL42.522
0283-1820-29HurriCaineTopical Anesthetic4 in 1 BOXGEL42
0283-1820-44HurriCaineTopical Anesthetic1.2 g in 1 SYRINGE, PLASTICGEL1.22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-1820-29GM - Gram0283-18200dcea260-544f-4c54-bf23-66427886aec712025-08-11
0283-1820-34GM - Gram0283-1820c28b5821-009f-4afe-846c-1ac1004fb0f512022-03-09
0283-1820-43GM - Gram0283-1820cdea8c76-b6cd-4a6a-9aaf-b1685b38f65b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-1820HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20231109_fe92637a-c88a-f9dd-e053-6294a90a7fa3.zip
0283-1820HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20241031_043bfbc3-c33a-78b7-e063-6294a90a1a5a.zip
0283-1820HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20231018_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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
ndc (product): 0283-1820
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
ndc (product): 0283-1820
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288HurriCaine 20 % Oral GelPSNfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDfe92637a-c88a-f9dd-e053-6294a90a7fa34
238910benzocaine 0.2 MG/MG Oral GelSCDfe92637a-c88a-f9dd-e053-6294a90a7fa34
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288Hurricaine 0.2 MG/MG Oral GelSYfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288Hurricaine 20 % Dental GelSYfe92637a-c88a-f9dd-e053-6294a90a7fa34
238910benzocaine 20 % Oral GelPSN043bfbc3-c33a-78b7-e063-6294a90a1a5a2
238910benzocaine 20 % Oral GelPSNc979e958-2042-471a-bf03-e84e686201062
996288HurriCaine 20 % Oral GelPSN043bfbc3-c33a-78b7-e063-6294a90a1a5a2
996288HurriCaine 20 % Oral GelPSNc979e958-2042-471a-bf03-e84e686201062
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDc979e958-2042-471a-bf03-e84e686201062
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD043bfbc3-c33a-78b7-e063-6294a90a1a5a2
238910benzocaine 0.2 MG/MG Oral GelSCD043bfbc3-c33a-78b7-e063-6294a90a1a5a2
238910benzocaine 0.2 MG/MG Oral GelSCDc979e958-2042-471a-bf03-e84e686201062
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYc979e958-2042-471a-bf03-e84e686201062
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY043bfbc3-c33a-78b7-e063-6294a90a1a5a2
996288Hurricaine 0.2 MG/MG Oral GelSYc979e958-2042-471a-bf03-e84e686201062
996288Hurricaine 0.2 MG/MG Oral GelSY043bfbc3-c33a-78b7-e063-6294a90a1a5a2
996288Hurricaine 20 % Dental GelSYc979e958-2042-471a-bf03-e84e686201062
996288Hurricaine 20 % Dental GelSY043bfbc3-c33a-78b7-e063-6294a90a1a5a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-1820-270028318202742.52 g in 1 TUBE (0283-1820-27) 42.52 g2023-08-31NoNoCurrent
0283-1820-29002831820294 SYRINGE, PLASTIC in 1 BOX (0283-1820-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-1820-44) 2023-08-01NoNoCurrent
0283-1820-34002831820344 SYRINGE, PLASTIC in 1 BOX (0283-1820-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-1820-43) 2021-01-310000-00-00NoNoCurrent
0283-1820-43002831820431.5 g in 1 SYRINGE, PLASTIC1.5 gHistorical
0283-1820-44002831820441.2 g in 1 SYRINGE, PLASTIC1.2 gHistorical