HurriCaine

Product NDC
0283-1820
11-digit product format
002831820
Labeler code
0283
Product ID
0283-1820_25a29681-8f39-619d-e063-6294a90a7924
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
2023-08-31
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 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
0283-1820-34HurriCaineTopical Anesthetic4 in 1 TRAYGEL44
0283-1820-43HurriCaineTopical Anesthetic1.5 g in 1 SYRINGE, PLASTICGEL1.54
0283-1820-27HurriCaineTopical Anesthetic42.52 g in 1 TUBEGEL42.522
0283-1820-29HurriCaineTopical Anesthetic4 in 1 BOXGEL42
0283-1820-44HurriCaineTopical Anesthetic1.2 g in 1 SYRINGE, PLASTICGEL1.22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-1820-29GM - Gram0283-18200dcea260-544f-4c54-bf23-66427886aec712025-08-11
0283-1820-34GM - Gram0283-1820c28b5821-009f-4afe-846c-1ac1004fb0f512022-03-09
0283-1820-43GM - Gram0283-1820cdea8c76-b6cd-4a6a-9aaf-b1685b38f65b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-1820HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20231109_fe92637a-c88a-f9dd-e053-6294a90a7fa3.zip
0283-1820HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20241031_043bfbc3-c33a-78b7-e063-6294a90a1a5a.zip
0283-1820HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20231018_c979e958-2042-471a-bf03-e84e68620106.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288HurriCaine 20 % Oral GelPSNfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDfe92637a-c88a-f9dd-e053-6294a90a7fa34
238910benzocaine 0.2 MG/MG Oral GelSCDfe92637a-c88a-f9dd-e053-6294a90a7fa34
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288Hurricaine 0.2 MG/MG Oral GelSYfe92637a-c88a-f9dd-e053-6294a90a7fa34
996288Hurricaine 20 % Dental GelSYfe92637a-c88a-f9dd-e053-6294a90a7fa34
238910benzocaine 20 % Oral GelPSN043bfbc3-c33a-78b7-e063-6294a90a1a5a2
238910benzocaine 20 % Oral GelPSNc979e958-2042-471a-bf03-e84e686201062
996288HurriCaine 20 % Oral GelPSN043bfbc3-c33a-78b7-e063-6294a90a1a5a2
996288HurriCaine 20 % Oral GelPSNc979e958-2042-471a-bf03-e84e686201062
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDc979e958-2042-471a-bf03-e84e686201062
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD043bfbc3-c33a-78b7-e063-6294a90a1a5a2
238910benzocaine 0.2 MG/MG Oral GelSCD043bfbc3-c33a-78b7-e063-6294a90a1a5a2
238910benzocaine 0.2 MG/MG Oral GelSCDc979e958-2042-471a-bf03-e84e686201062
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYc979e958-2042-471a-bf03-e84e686201062
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY043bfbc3-c33a-78b7-e063-6294a90a1a5a2
996288Hurricaine 0.2 MG/MG Oral GelSYc979e958-2042-471a-bf03-e84e686201062
996288Hurricaine 0.2 MG/MG Oral GelSY043bfbc3-c33a-78b7-e063-6294a90a1a5a2
996288Hurricaine 20 % Dental GelSYc979e958-2042-471a-bf03-e84e686201062
996288Hurricaine 20 % Dental GelSY043bfbc3-c33a-78b7-e063-6294a90a1a5a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-1820-270028318202742.52 g in 1 TUBE (0283-1820-27) 42.52 g2023-08-31NoNoHistorical
0283-1820-29002831820294 SYRINGE, PLASTIC in 1 BOX (0283-1820-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-1820-44) 2023-08-01NoNoHistorical
0283-1820-34002831820344 SYRINGE, PLASTIC in 1 BOX (0283-1820-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-1820-43) 2021-01-310000-00-00NoNoCurrent
0283-1820-43002831820431.5 g in 1 SYRINGE, PLASTIC1.5 gHistorical
0283-1820-44002831820441.2 g in 1 SYRINGE, PLASTIC1.2 gHistorical