FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-1886
11-digit product format
002831886
Labeler code
0283
Product ID
0283-1886_259047a5-da5a-2029-e063-6294a90a8db8
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
1986-08-15
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 Liquid
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
308657Internal RxNorm lookup
808062Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f70fa3fc-cd65-4a80-9efd-129e98fd3998Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-1886-31HurriCaineTopical Anesthetic Liquid29.6 g in 1 BOTTLE, PLASTICLIQUID29.625

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-1886-31ML - Milliliter0283-188695997612-3036-4406-9261-9d7d76533f7d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]5
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]5
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]5
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-1886HURRICAINE TOPICAL ANESTHETIC LIQUID (BENZOCAINE) LIQUID [BEUTLICH PHARMACEUTICALS, LLC]25Current NDC, Legacy NDC, 1 package rows20241030_f70fa3fc-cd65-4a80-9efd-129e98fd3998.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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moon Charcoal Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c55f7b3-fea1-58f3-e063-6394a90a3bde2023-12-12WarningsExact identifier
application number: M022
ORCA Complete Menthol Pain RelieverMENTHOLORCA Products, LLC99990e27-d66b-4d61-97f2-6a76066eb8b82023-12-08WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc0070858b-e02e-431f-a7c2-313fef01791b2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incd1802f08-80cb-41dd-b34d-9c576b101ddb2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSNf70fa3fc-cd65-4a80-9efd-129e98fd399825
808062HurriCaine Oral Anesthetic 20 % Mucous Membrane Topical SolutionPSNf70fa3fc-cd65-4a80-9efd-129e98fd399825
808062benzocaine 200 MG/ML Mucous Membrane Topical Solution [Hurricaine]SBDf70fa3fc-cd65-4a80-9efd-129e98fd399825
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCDf70fa3fc-cd65-4a80-9efd-129e98fd399825
308657benzocaine 20 % Mucous Membrane Topical SolutionSYf70fa3fc-cd65-4a80-9efd-129e98fd399825
808062Hurricaine 20 % Mucous Membrane Topical SolutionSYf70fa3fc-cd65-4a80-9efd-129e98fd399825
808062Hurricaine 200 MG/ML Mucous Membrane Topical SolutionSYf70fa3fc-cd65-4a80-9efd-129e98fd399825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-1886-17002831886171 g in 1 PACKET (0283-1886-17) 1 g2020-01-280000-00-00NoNoCurrent
0283-1886-310028318863129.6 g in 1 BOTTLE, PLASTIC (0283-1886-31) 29.6 g1986-08-150000-00-00NoNoCurrent