FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0998
11-digit product format
002830998
Labeler code
0283
Product ID
0283-0998_25901b79-d6be-4693-e063-6394a90ae2cb
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL; PERIODONTAL
Labeler
Beutlich Pharmaceuticals LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-09-15
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
0dd15227-6603-42ac-9a5f-f2dc49e0382aAvailable 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
0283-0998-31HurriCaineTopical Anesthetic28.4 g in 1 BOTTLE, PLASTICGEL28.445
0283-0998-45HurriCaineTopical Anesthetic0.5 g in 1 CUP, UNIT-DOSEGEL0.57
0283-0998-59HurriCaineTopical Anesthetic60 in 1 BOXGEL607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0998-31GM - Gram0283-0998f96ceb57-12be-4842-946b-158f461f636d12013-02-13
0283-0998-45EA - Each0283-099897d745ed-6d9a-427f-b2ad-e46f232a832912022-03-09
0283-0998-59EA - Each0283-0998c3dbf05f-6e58-480d-98c7-ee315e4ab04112022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]13
BENZOCAINEACTIVE MOIETYU3RSY48JW5HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]13
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]13
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYHURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0998HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]45Current NDC, Legacy NDC, 1 package rows20250110_723da3ae-3f1f-4962-920b-f2a30c8c3253.zip
0283-0998HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20241030_0dd15227-6603-42ac-9a5f-f2dc49e0382a.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 31 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
application number: M022
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
application number: M022
Red Cross Oral Pain ReliefBENZOCAINEThe Mentholatum Companycbd41429-f730-4577-9f06-ef1831cf62e12024-12-17WarningsExact identifier
application number: M022
Red Cross Canker SoreBENZOCAINEThe Mentholatum Company54cfff96-6665-4b36-a15d-10bf6cf3a1f92024-12-17WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESIN1169566442981217f-f250-c090-e063-6294a90a85b02024-12-17WarningsExact identifier
application number: M022
Kank-A Mouth PainBENZOCAINEBlistex Inc.eebc03ba-f849-4e70-a653-834f383b6aa42024-12-17WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8282a4a6-b77c-75fc-e053-2991aa0ad4ac2024-12-16WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.9452bff4-8c08-eff9-e053-2a95a90a67ed2024-12-16WarningsExact identifier
application number: M022
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
application number: M022
KANKA SoftBrushBENZOCAINE AND ZINC CHLORIDEBlistex Inc093f3545-1d8e-48a3-a533-e9c3ae6d740b2024-12-12WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.826eaef8-4457-3dc2-e053-2991aa0a528b2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8281700c-10f9-841c-e053-2991aa0a918f2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.82824416-80de-76bd-e053-2a91aa0ad8b52024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.e3da0e63-a891-72bd-e053-2a95a90a58bc2024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories, Inc.e3d924b5-0788-46d3-e053-2995a90a027b2024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.fa433031-7376-0e5b-e053-6394a90a5f752024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.763e8234-60be-4b1f-9f78-01c574f35d0a2024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.989f8509-cd28-48e7-9aa1-baddfbcac95a2024-12-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN723da3ae-3f1f-4962-920b-f2a30c8c325345
996288HurriCaine 20 % Oral GelPSN723da3ae-3f1f-4962-920b-f2a30c8c325345
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD723da3ae-3f1f-4962-920b-f2a30c8c325345
238910benzocaine 0.2 MG/MG Oral GelSCD723da3ae-3f1f-4962-920b-f2a30c8c325345
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY723da3ae-3f1f-4962-920b-f2a30c8c325345
996288Hurricaine 0.2 MG/MG Oral GelSY723da3ae-3f1f-4962-920b-f2a30c8c325345
996288Hurricaine 20 % Dental GelSY723da3ae-3f1f-4962-920b-f2a30c8c325345
238910benzocaine 20 % Oral GelPSN0dd15227-6603-42ac-9a5f-f2dc49e0382a7
996288HurriCaine 20 % Oral GelPSN0dd15227-6603-42ac-9a5f-f2dc49e0382a7
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD0dd15227-6603-42ac-9a5f-f2dc49e0382a7
238910benzocaine 0.2 MG/MG Oral GelSCD0dd15227-6603-42ac-9a5f-f2dc49e0382a7
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY0dd15227-6603-42ac-9a5f-f2dc49e0382a7
996288Hurricaine 0.2 MG/MG Oral GelSY0dd15227-6603-42ac-9a5f-f2dc49e0382a7
996288Hurricaine 20 % Dental GelSY0dd15227-6603-42ac-9a5f-f2dc49e0382a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0998-310028309983128.4 g in 1 BOTTLE, PLASTIC (0283-0998-31) 28.4 g1998-09-150000-00-00NoNoCurrent
0283-0998-43002830998431 g in 1 PACKET (0283-0998-43) 1 g2020-01-280000-00-00NoNoCurrent
0283-0998-45002830998450.5 g in 1 CUP, UNIT-DOSE0.5 gHistorical
0283-0998-590028309985960 CUP, UNIT-DOSE in 1 BOX (0283-0998-59) / .5 g in 1 CUP, UNIT-DOSE (0283-0998-45) 2021-01-310000-00-00NoNoCurrent