FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0886
11-digit product format
002830886
Labeler code
0283
Product ID
0283-0886_2b373b9e-eda7-72e5-e063-6394a90abf5e
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
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 Gel
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
fef1f48c-e89d-4b75-9ba0-b1b068daf582Available 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
0283-0886-31HurriCaineTopical Anesthetic Gel28.4 g in 1 BOTTLE, PLASTICGEL28.425
0283-0886-43HurriCaineTopical Anesthetic Gel1 g in 1 PACKETGEL125
0283-0886-45HurriCaineTopical Anesthetic Gel0.5 g in 1 CUP, UNIT-DOSEGEL0.57
0283-0886-59HurriCaineTopical Anesthetic Gel60 in 1 BOXGEL607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0886-31GM - Gram0283-08862edc4b3c-a2da-4c70-8d3a-05e6e0f03ecd12012-07-24
0283-0886-45EA - Each0283-0886937025f2-6b1b-4aee-a264-f789130a09aa12022-03-09
0283-0886-59EA - Each0283-0886fba5e691-828e-48d3-b412-cbb51a94ac1b12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5
BenzocaineACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PHURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0886HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]25Current NDC, Legacy NDC, 2 package rows20250110_fef1f48c-e89d-4b75-9ba0-b1b068daf582.zip
0283-0886HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20241030_4c278122-2643-46bf-9e44-11985210a16e.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
238910benzocaine 20 % Oral GelPSNfef1f48c-e89d-4b75-9ba0-b1b068daf58225
996288HurriCaine 20 % Oral GelPSNfef1f48c-e89d-4b75-9ba0-b1b068daf58225
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDfef1f48c-e89d-4b75-9ba0-b1b068daf58225
238910benzocaine 0.2 MG/MG Oral GelSCDfef1f48c-e89d-4b75-9ba0-b1b068daf58225
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYfef1f48c-e89d-4b75-9ba0-b1b068daf58225
996288Hurricaine 0.2 MG/MG Oral GelSYfef1f48c-e89d-4b75-9ba0-b1b068daf58225
996288Hurricaine 20 % Dental GelSYfef1f48c-e89d-4b75-9ba0-b1b068daf58225
238910benzocaine 20 % Oral GelPSN4c278122-2643-46bf-9e44-11985210a16e7
996288HurriCaine 20 % Oral GelPSN4c278122-2643-46bf-9e44-11985210a16e7
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD4c278122-2643-46bf-9e44-11985210a16e7
238910benzocaine 0.2 MG/MG Oral GelSCD4c278122-2643-46bf-9e44-11985210a16e7
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY4c278122-2643-46bf-9e44-11985210a16e7
996288Hurricaine 0.2 MG/MG Oral GelSY4c278122-2643-46bf-9e44-11985210a16e7
996288Hurricaine 20 % Dental GelSY4c278122-2643-46bf-9e44-11985210a16e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0886-310028308863128.4 g in 1 BOTTLE, PLASTIC (0283-0886-31) 28.4 g1986-08-150000-00-00NoNoCurrent
0283-0886-43002830886431 g in 1 PACKET (0283-0886-43) 1 g2020-01-280000-00-00NoNoCurrent
0283-0886-45002830886450.5 g in 1 CUP, UNIT-DOSE0.5 gHistorical
0283-0886-590028308865960 CUP, UNIT-DOSE in 1 BOX (0283-0886-59) / .5 g in 1 CUP, UNIT-DOSE (0283-0886-45) 2021-01-310000-00-00NoNoCurrent