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

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 Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 996288

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

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