FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0220
11-digit product format
002830220
Labeler code
0283
Product ID
0283-0220_2b36463d-2787-74ec-e063-6294a90a0154
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
0283-0220-27HurriCaineTopical Anesthetic42.52 g in 1 TUBEGEL42.522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0220-34GM - Gram0283-022063fb746b-ef08-43f3-b5b2-67291024d57312022-03-09
0283-0220-43GM - Gram0283-02202d7aa6ec-d155-4fda-beb7-66deb9adf2ac12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0220HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20250110_043c336f-60e3-dc23-e063-6294a90a4b13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN043c336f-60e3-dc23-e063-6294a90a4b132
996288HurriCaine 20 % Oral GelPSN043c336f-60e3-dc23-e063-6294a90a4b132
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD043c336f-60e3-dc23-e063-6294a90a4b132
238910benzocaine 0.2 MG/MG Oral GelSCD043c336f-60e3-dc23-e063-6294a90a4b132
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY043c336f-60e3-dc23-e063-6294a90a4b132
996288Hurricaine 0.2 MG/MG Oral GelSY043c336f-60e3-dc23-e063-6294a90a4b132
996288Hurricaine 20 % Dental GelSY043c336f-60e3-dc23-e063-6294a90a4b132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0220-270028302202742.52 g in 1 TUBE (0283-0220-27) 42.52 g2023-08-31NoNoCurrent
0283-0220-34002830220344 SYRINGE, PLASTIC in 1 BOX (0283-0220-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-0220-43) 2021-01-310000-00-00NoNoCurrent