FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0871
Requested package NDC
0283-0871-59
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 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 1 of 42 · 821 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-07-06WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-07-03WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
application number: M022
GingiCaine gel, CherryGINGICAINE GEL, CHERRY FLAVORGingi-Pak a Division of the Belport6274d92e-c4e9-34fd-e053-2991aa0ae6042026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Mint JulepGINGICAINE GEL, MINT JULEP FLABVORGingi-Pak a Division of the Belport6285fe10-08ba-8044-e053-2991aa0a8e8b2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
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