FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0293
11-digit product format
002830293
Labeler code
0283
Product ID
0283-0293_2b364db1-b3c2-9b01-e063-6294a90ac13b
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
1993-02-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0283-02930283-0293-53DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
e67b8def-c728-4952-9b35-874643cbe0f1Available 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
0283-0293-31HurriCaineTopical Anesthetic Gel28.4 g in 1 BOTTLE, PLASTICGEL28.425
0283-0293-43HurriCaineTopical Anesthetic Gel1 g in 1 PACKETGEL125
0283-0293-45HurriCaineTopical Anesthetic Gel0.5 g in 1 CUP, UNIT-DOSEGEL0.58
0283-0293-59HurriCaineTopical Anesthetic Gel60 in 1 BOXGEL608
0283-0293-45HurriCaineTopical Anesthetic Gel0.5 g in 1 CUP, UNIT-DOSEGEL0.55
0283-0293-53HurriCaineTopical Anesthetic Gel60 in 1 BOXGEL605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0293-31GM - Gram0283-029398d97e9b-95bd-43e2-b5cf-bf5d3dea299612012-07-24
0283-0293-45EA - Each0283-0293db753360-afca-4d14-b286-665de8ff5c2b12022-03-09
0283-0293-59EA - Each0283-0293411efd25-85d0-4258-85c0-6ddd8377461912022-03-09

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
0283-0293HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]25Current NDC, Legacy NDC, 2 package rows20250110_c113773b-dfb0-4797-ae0e-ecc06bfffd68.zip
0283-0293HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 package rows20250110_106b6115-d043-4050-80c6-1d82456dea02.zip
0283-0293HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20250110_e67b8def-c728-4952-9b35-874643cbe0f1.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 GelPSNc113773b-dfb0-4797-ae0e-ecc06bfffd6825
996288HurriCaine 20 % Oral GelPSNc113773b-dfb0-4797-ae0e-ecc06bfffd6825
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDc113773b-dfb0-4797-ae0e-ecc06bfffd6825
238910benzocaine 0.2 MG/MG Oral GelSCDc113773b-dfb0-4797-ae0e-ecc06bfffd6825
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYc113773b-dfb0-4797-ae0e-ecc06bfffd6825
996288Hurricaine 0.2 MG/MG Oral GelSYc113773b-dfb0-4797-ae0e-ecc06bfffd6825
996288Hurricaine 20 % Dental GelSYc113773b-dfb0-4797-ae0e-ecc06bfffd6825
238910benzocaine 20 % Oral GelPSN106b6115-d043-4050-80c6-1d82456dea028
996288HurriCaine 20 % Oral GelPSN106b6115-d043-4050-80c6-1d82456dea028
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD106b6115-d043-4050-80c6-1d82456dea028
238910benzocaine 0.2 MG/MG Oral GelSCD106b6115-d043-4050-80c6-1d82456dea028
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY106b6115-d043-4050-80c6-1d82456dea028
996288Hurricaine 0.2 MG/MG Oral GelSY106b6115-d043-4050-80c6-1d82456dea028
996288Hurricaine 20 % Dental GelSY106b6115-d043-4050-80c6-1d82456dea028
238910benzocaine 20 % Oral GelPSNe67b8def-c728-4952-9b35-874643cbe0f15
996288HurriCaine 20 % Oral GelPSNe67b8def-c728-4952-9b35-874643cbe0f15
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDe67b8def-c728-4952-9b35-874643cbe0f15
238910benzocaine 0.2 MG/MG Oral GelSCDe67b8def-c728-4952-9b35-874643cbe0f15
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYe67b8def-c728-4952-9b35-874643cbe0f15
996288Hurricaine 0.2 MG/MG Oral GelSYe67b8def-c728-4952-9b35-874643cbe0f15
996288Hurricaine 20 % Dental GelSYe67b8def-c728-4952-9b35-874643cbe0f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0293-310028302933128.4 g in 1 BOTTLE, PLASTIC (0283-0293-31) 28.4 g1993-02-150000-00-00NoNoCurrent
0283-0293-43002830293431 g in 1 PACKET (0283-0293-43) 1 g2020-01-280000-00-00NoNoCurrent
0283-0293-45002830293450.5 g in 1 CUP, UNIT-DOSE0.5 gHistorical
0283-0293-530028302935360 CUP, UNIT-DOSE in 1 BOX (0283-0293-53) > .5 g in 1 CUP, UNIT-DOSE (0283-0293-45) 2021-01-310000-00-00NoNoCurrent
0283-0293-590028302935960 CUP, UNIT-DOSE in 1 BOX (0283-0293-59) / .5 g in 1 CUP, UNIT-DOSE (0283-0293-45) 2021-01-310000-00-00NoNoCurrent