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

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 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

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