FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0622
11-digit product format
002830622
Labeler code
0283
Product ID
0283-0622_0b513cb2-2a00-0a1e-e063-6394a90a11af
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
2022-12-15
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 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
0283-0622-34HurriCaineTopical Anesthetic4 in 1 BOXGEL45
0283-0622-43HurriCaineTopical Anesthetic1.2 g in 1 SYRINGE, PLASTICGEL1.25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0622-34GM - Gram0283-0622aacd4bc5-1217-4f6d-bb96-fd3f02d6616412023-08-08
0283-0622-43GM - Gram0283-062232e9359a-c42e-4df8-8364-13c032f76d9d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0622HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5Current NDC, 2 package rows20231130_f3bf106c-5320-ced2-e053-2a95a90a71ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNf3bf106c-5320-ced2-e053-2a95a90a71ac5
996288HurriCaine 20 % Oral GelPSNf3bf106c-5320-ced2-e053-2a95a90a71ac5
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBDf3bf106c-5320-ced2-e053-2a95a90a71ac5
238910benzocaine 0.2 MG/MG Oral GelSCDf3bf106c-5320-ced2-e053-2a95a90a71ac5
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYf3bf106c-5320-ced2-e053-2a95a90a71ac5
996288Hurricaine 0.2 MG/MG Oral GelSYf3bf106c-5320-ced2-e053-2a95a90a71ac5
996288Hurricaine 20 % Dental GelSYf3bf106c-5320-ced2-e053-2a95a90a71ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0283-0622-34002830622344 SYRINGE, PLASTIC in 1 BOX (0283-0622-34) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0622-43) 2022-12-15NoNoCurrent
0283-0622-43002830622431.2 g in 1 SYRINGE, PLASTIC1.2 gHistorical