FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-1016
11-digit product format
002831016
Labeler code
0283
Product ID
0283-1016_259039d7-ae05-7abc-e063-6294a90af1fd
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
2016-10-15
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
0605d5d6-82bd-415e-b5cb-e273f934a4a7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-1016-00HurriCaineTopical Anesthetic28.4 g in 1 BOTTLE, PLASTICGEL28.445
0283-1016-31HurriCaineTopical Anesthetic1 in 1 BOXGEL145
0283-1016-43HurriCaineTopical Anesthetic1 g in 1 PACKETGEL145
0283-1016-45HurriCaineTopical Anesthetic0.5 g in 1 CUP, UNIT-DOSEGEL0.56
0283-1016-59HurriCaineTopical Anesthetic60 in 1 BOXGEL606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-1016-31GM - Gram0283-101663b9ec1c-583b-4b8e-bdc3-b8b65595956112018-05-09
0283-1016-45EA - Each0283-10168385d8b9-ec94-4266-84a9-7b44ed56fa2412022-03-09
0283-1016-59EA - Each0283-10168952eeef-e587-474c-98cf-a7386719c33512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-1016HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]45Current NDC, Legacy NDC, 3 package rows20250110_42521b29-67e4-4a16-848d-7e6ba4a7ece2.zip
0283-1016HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20241030_0605d5d6-82bd-415e-b5cb-e273f934a4a7.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 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitive Whitening Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.c25b6a95-e604-48e3-bc55-595969d1ce9b2025-12-23WarningsExact identifier
application number: M022
parodontax Active Gum RepairSTANNOUS FLUORIDEHaleon US Holdings LLCb51ccdd9-c0af-4caa-ad97-ad1d1423b76b2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLC59bb84d6-6fd3-4586-bccf-7dc45cbbb39c2025-12-22WarningsExact identifier
application number: M022
parodontax Complete ProtectionSTANNOUS FLUORIDEHaleon US Holdings LLCf6912712-ce9b-44aa-8953-b9a8d420f4582025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair WhiteningSTANNOUS FLUORIDEHaleon US Holdings LLC817e804c-e55e-4d77-9ab9-ff54ae7947252025-12-22WarningsExact identifier
application number: M022
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
application number: M022
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
application number: M022
R B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.410c40fd-cf94-0301-e063-6294a90ae2de2025-12-18WarningsExact identifier
application number: M022
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
application number: M022
Res B onePHOSPHATIDYLSERINE, ZINC OXIDENPG Bio Pharmaceuticals Co.,Ltd.21469f58-1d70-774f-e063-6294a90af0392025-12-18WarningsExact identifier
application number: M022
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
application number: M022
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
application number: M022
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.c13761e0-d45d-4e0f-ac41-428e005f96bb2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.6dca566b-cb6a-43c4-b6e2-f2bad77fb9322025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab2025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.7ede08e5-2dfe-4183-905d-28d1cea424072025-12-17WarningsExact identifier
application number: M022
Ipana 20% Benzocaine TopicalBENZOCAINEMaxill Inc.9de36e4f-f966-4a58-b4bf-9ac3b86b3f092025-12-17WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDECVS PHARMACY, INC3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb22025-12-17WarningsExact identifier
application number: M022
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN42521b29-67e4-4a16-848d-7e6ba4a7ece245
996288HurriCaine 20 % Oral GelPSN42521b29-67e4-4a16-848d-7e6ba4a7ece245
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD42521b29-67e4-4a16-848d-7e6ba4a7ece245
238910benzocaine 0.2 MG/MG Oral GelSCD42521b29-67e4-4a16-848d-7e6ba4a7ece245
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY42521b29-67e4-4a16-848d-7e6ba4a7ece245
996288Hurricaine 0.2 MG/MG Oral GelSY42521b29-67e4-4a16-848d-7e6ba4a7ece245
996288Hurricaine 20 % Dental GelSY42521b29-67e4-4a16-848d-7e6ba4a7ece245
238910benzocaine 20 % Oral GelPSN0605d5d6-82bd-415e-b5cb-e273f934a4a76
996288HurriCaine 20 % Oral GelPSN0605d5d6-82bd-415e-b5cb-e273f934a4a76
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD0605d5d6-82bd-415e-b5cb-e273f934a4a76
238910benzocaine 0.2 MG/MG Oral GelSCD0605d5d6-82bd-415e-b5cb-e273f934a4a76
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY0605d5d6-82bd-415e-b5cb-e273f934a4a76
996288Hurricaine 0.2 MG/MG Oral GelSY0605d5d6-82bd-415e-b5cb-e273f934a4a76
996288Hurricaine 20 % Dental GelSY0605d5d6-82bd-415e-b5cb-e273f934a4a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-1016-000028310160028.4 g in 1 BOTTLE, PLASTIC28.4 gHistorical
0283-1016-31002831016311 BOTTLE, PLASTIC in 1 BOX (0283-1016-31) / 28.4 g in 1 BOTTLE, PLASTIC (0283-1016-00) 2016-10-150000-00-00NoNoCurrent
0283-1016-43002831016431 g in 1 PACKET (0283-1016-43) 1 g2020-01-280000-00-00NoNoCurrent
0283-1016-45002831016450.5 g in 1 CUP, UNIT-DOSE0.5 gHistorical
0283-1016-590028310165960 CUP, UNIT-DOSE in 1 BOX (0283-1016-59) / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45) 2021-01-310000-00-00NoNoCurrent