FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0920
11-digit product format
002830920
Labeler code
0283
Product ID
0283-0920_09a6bf06-ea77-5aee-e063-6294a90a3bb2
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
2021-01-31
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 packagepackage0283-09200283-0920-34DDiscontinued by firm2026-10-21

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
0d2c8c0c-4c72-4400-b3b5-ed578fa35167Available 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
0283-0920-34HurriCaineTopical Anesthetic4 in 1 BOXGEL45
0283-0920-43HurriCaineTopical Anesthetic1.5 g in 1 SYRINGE, PLASTICGEL1.55
0283-0920-27HurriCaineTopical Anesthetic42.52 g in 1 TUBEGEL42.522
0283-0920-29HurriCaineTopical Anesthetic4 in 1 BOXGEL41
0283-0920-44HurriCaineTopical Anesthetic1.2 g in 1 SYRINGE, PLASTICGEL1.21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0920-34GM - Gram0283-09202672c833-acff-445c-a3e1-1fe94af3105e12023-08-08
0283-0920-43GM - Gram0283-09200488a37f-9ef9-4d9e-b8c2-094f9b20a74712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0920HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20231109_0d2c8c0c-4c72-4400-b3b5-ed578fa35167.zip
0283-0920HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20241031_043a3cb4-f560-0ffd-e063-6394a90a2ff6.zip
0283-0920HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20231130_0b517321-25ed-2676-e063-6294a90ab4c9.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 23 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc9315bd7c-44db-42c8-a9df-aaaa66153c172025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc56185c5f-6f6c-4976-bf18-540b076d90a62025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc88cadb9e-17ab-44bb-b4fe-fcfd6b7334652025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf71b0ab5-0605-4807-b835-903e19aaf2a82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN0d2c8c0c-4c72-4400-b3b5-ed578fa351675
996288HurriCaine 20 % Oral GelPSN0d2c8c0c-4c72-4400-b3b5-ed578fa351675
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD0d2c8c0c-4c72-4400-b3b5-ed578fa351675
238910benzocaine 0.2 MG/MG Oral GelSCD0d2c8c0c-4c72-4400-b3b5-ed578fa351675
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY0d2c8c0c-4c72-4400-b3b5-ed578fa351675
996288Hurricaine 0.2 MG/MG Oral GelSY0d2c8c0c-4c72-4400-b3b5-ed578fa351675
996288Hurricaine 20 % Dental GelSY0d2c8c0c-4c72-4400-b3b5-ed578fa351675
238910benzocaine 20 % Oral GelPSN043a3cb4-f560-0ffd-e063-6394a90a2ff62
996288HurriCaine 20 % Oral GelPSN043a3cb4-f560-0ffd-e063-6394a90a2ff62
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD043a3cb4-f560-0ffd-e063-6394a90a2ff62
238910benzocaine 0.2 MG/MG Oral GelSCD043a3cb4-f560-0ffd-e063-6394a90a2ff62
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY043a3cb4-f560-0ffd-e063-6394a90a2ff62
996288Hurricaine 0.2 MG/MG Oral GelSY043a3cb4-f560-0ffd-e063-6394a90a2ff62
996288Hurricaine 20 % Dental GelSY043a3cb4-f560-0ffd-e063-6394a90a2ff62
238910benzocaine 20 % Oral GelPSN0b517321-25ed-2676-e063-6294a90ab4c91
996288HurriCaine 20 % Oral GelPSN0b517321-25ed-2676-e063-6294a90ab4c91
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD0b517321-25ed-2676-e063-6294a90ab4c91
238910benzocaine 0.2 MG/MG Oral GelSCD0b517321-25ed-2676-e063-6294a90ab4c91
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY0b517321-25ed-2676-e063-6294a90ab4c91
996288Hurricaine 0.2 MG/MG Oral GelSY0b517321-25ed-2676-e063-6294a90ab4c91
996288Hurricaine 20 % Dental GelSY0b517321-25ed-2676-e063-6294a90ab4c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0920-270028309202742.52 g in 1 TUBE (0283-0920-27) 42.52 g2023-08-31NoNoCurrent
0283-0920-29002830920294 SYRINGE, PLASTIC in 1 BOX (0283-0920-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0920-44) 2023-03-15NoNoCurrent
0283-0920-34002830920344 SYRINGE, PLASTIC in 1 BOX (0283-0920-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-0920-43) 2021-01-310000-00-00NoNoCurrent
0283-0920-43002830920431.5 g in 1 SYRINGE, PLASTIC1.5 gHistorical
0283-0920-44002830920441.2 g in 1 SYRINGE, PLASTIC1.2 gHistorical