FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0871
11-digit product format
002830871
Labeler code
0283
Product ID
0283-0871_258ffae7-a428-8dae-e063-6294a90adcc0
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
1971-08-15
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
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
1f3d68f6-afd6-42e7-b3e5-210228c8e7deAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0283-0871-592023-02-01C16284748780-1f386c649-f23d-0266-e053-dadaa90a7c1aHurriCaine Unit Dose Gel and Swab - Cherry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0871-31HurriCaineTopical Anesthetic1 in 1 BOXGEL127
0283-0871-31HurriCaineTopical Anesthetic28.4 g in 1 BOTTLE, PLASTICGEL28.427
0283-0871-45HurriCaineTopical Anesthetic0.5 g in 1 CUP, UNIT-DOSEGEL0.526
0283-0871-59HurriCaineTopical Anesthetic60 in 1 BOXGEL6026
0283-0871-01HurriCaineTopical Anesthetic5.25 g in 1 TUBEGEL5.2525
0283-0871-12HurriCaineTopical Anesthetic12 in 1 CELLO PACKGEL1225
0283-0871-75HurriCaineTopical Anesthetic1 in 1 BOXGEL125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0871-12GM - Gram0283-08716691d8d3-e365-4b3c-ac65-03bdf46d01f612012-07-24
0283-0871-31GM - Gram0283-087113270ff7-44c9-4115-bc6e-688a24f23ac512012-07-24
0283-0871-45EA - Each0283-08717e35be3f-eaad-4633-ae1f-b5241f28592012022-03-09
0283-0871-59EA - Each0283-08714ee3acb3-dc3a-4da0-8528-b4c60fc376b512022-03-09
0283-0871-75GM - Gram0283-08712f16edc3-01b9-467d-b7e6-941c9305aff412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
POLYETHYLENE GLYCOL 3500INACTIVE INGREDIENTFVS1AZD90YHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0871HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]27Current NDC, Legacy NDC, 2 package rows20241030_1f3d68f6-afd6-42e7-b3e5-210228c8e7de.zip
0283-0871HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 2 package rows20250110_e628bd9f-99e5-4c71-ba8a-caa6c337de54.zip
0283-0871HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]24Current NDC, Legacy NDC, 3 package rows20250110_113cdb83-0fdd-40f2-8ee6-b771dca99713.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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
996288HurriCaine 20 % Oral GelPSN1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
238910benzocaine 0.2 MG/MG Oral GelSCD1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
996288Hurricaine 0.2 MG/MG Oral GelSY1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
996288Hurricaine 20 % Dental GelSY1f3d68f6-afd6-42e7-b3e5-210228c8e7de27
238910benzocaine 20 % Oral GelPSNe628bd9f-99e5-4c71-ba8a-caa6c337de5426
996288HurriCaine 20 % Oral GelPSNe628bd9f-99e5-4c71-ba8a-caa6c337de5426
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDe628bd9f-99e5-4c71-ba8a-caa6c337de5426
238910benzocaine 0.2 MG/MG Oral GelSCDe628bd9f-99e5-4c71-ba8a-caa6c337de5426
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYe628bd9f-99e5-4c71-ba8a-caa6c337de5426
996288Hurricaine 0.2 MG/MG Oral GelSYe628bd9f-99e5-4c71-ba8a-caa6c337de5426
996288Hurricaine 20 % Dental GelSYe628bd9f-99e5-4c71-ba8a-caa6c337de5426
238910benzocaine 20 % Oral GelPSN113cdb83-0fdd-40f2-8ee6-b771dca9971325
996288HurriCaine 20 % Oral GelPSN113cdb83-0fdd-40f2-8ee6-b771dca9971325
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD113cdb83-0fdd-40f2-8ee6-b771dca9971325
238910benzocaine 0.2 MG/MG Oral GelSCD113cdb83-0fdd-40f2-8ee6-b771dca9971325
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY113cdb83-0fdd-40f2-8ee6-b771dca9971325
996288Hurricaine 0.2 MG/MG Oral GelSY113cdb83-0fdd-40f2-8ee6-b771dca9971325
996288Hurricaine 20 % Dental GelSY113cdb83-0fdd-40f2-8ee6-b771dca9971325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0871-01002830871015.25 g in 1 TUBE5.25 gHistorical
0283-0871-120028308711212 BOX in 1 CELLO PACK (0283-0871-12) / 1 TUBE in 1 BOX (0283-0871-75) / 5.25 g in 1 TUBE (0283-0871-01) 12 box1971-08-150000-00-00NoNoCurrent
0283-0871-31002830871311 BOTTLE, PLASTIC in 1 BOX (0283-0871-31) / 28.4 g in 1 BOTTLE, PLASTIC1971-08-150000-00-00NoNoCurrent
0283-0871-43002830871431 g in 1 PACKET (0283-0871-43) 1 g2019-01-280000-00-00NoNoCurrent
0283-0871-45002830871450.5 g in 1 CUP, UNIT-DOSE0.5 gHistorical
0283-0871-590028308715960 CUP, UNIT-DOSE in 1 BOX (0283-0871-59) / .5 g in 1 CUP, UNIT-DOSE (0283-0871-45) 2021-01-310000-00-00NoNoCurrent
0283-0871-75002830871751 in 1 BOXHistorical