FDA.reportPublic FDA data

HurriCaine

Product NDC
0283-0520
11-digit product format
002830520
Labeler code
0283
Product ID
0283-0520_09a6a044-a5d3-3bc6-e063-6294a90a98d6
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
2021-01-31
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
0283-0520-34HurriCaineTopical Anesthetic4 in 1 BOXGEL44
0283-0520-43HurriCaineTopical Anesthetic1.5 g in 1 SYRINGE, PLASTICGEL1.54
0283-0520-27HurriCaineTopical Anesthetic42.52 g in 1 TUBEGEL42.522
0283-0520-29HurriCaineTopical Anesthetic4 in 1 BOXGEL41
0283-0520-44HurriCaineTopical Anesthetic1.2 g in 1 SYRINGE, PLASTICGEL1.21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0520-29GM - Gram0283-0520554eede2-3d11-4396-9ced-9cba77b5892d12025-08-11
0283-0520-34GM - Gram0283-0520ddf73041-f8e7-4849-a9da-69791aa8d46512022-03-09
0283-0520-43GM - Gram0283-0520546d26a1-dac8-4fe0-a30b-bed04a39f25f12022-03-09
0283-0520-44GM - Gram0283-0520bcf5c7ef-3cfc-47c3-b4ab-d1fadeed1ee912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0520HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20231109_33fbdbc7-e10d-4181-926f-9b591b5b07e3.zip
0283-0520HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20241031_043bfbc3-c33b-78b7-e063-6294a90a1a5a.zip
0283-0520HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20231130_0b51b67c-03ac-5730-e063-6394a90a5060.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN33fbdbc7-e10d-4181-926f-9b591b5b07e34
996288HurriCaine 20 % Oral GelPSN33fbdbc7-e10d-4181-926f-9b591b5b07e34
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD33fbdbc7-e10d-4181-926f-9b591b5b07e34
238910benzocaine 0.2 MG/MG Oral GelSCD33fbdbc7-e10d-4181-926f-9b591b5b07e34
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY33fbdbc7-e10d-4181-926f-9b591b5b07e34
996288Hurricaine 0.2 MG/MG Oral GelSY33fbdbc7-e10d-4181-926f-9b591b5b07e34
996288Hurricaine 20 % Dental GelSY33fbdbc7-e10d-4181-926f-9b591b5b07e34
238910benzocaine 20 % Oral GelPSN043bfbc3-c33b-78b7-e063-6294a90a1a5a2
996288HurriCaine 20 % Oral GelPSN043bfbc3-c33b-78b7-e063-6294a90a1a5a2
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD043bfbc3-c33b-78b7-e063-6294a90a1a5a2
238910benzocaine 0.2 MG/MG Oral GelSCD043bfbc3-c33b-78b7-e063-6294a90a1a5a2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY043bfbc3-c33b-78b7-e063-6294a90a1a5a2
996288Hurricaine 0.2 MG/MG Oral GelSY043bfbc3-c33b-78b7-e063-6294a90a1a5a2
996288Hurricaine 20 % Dental GelSY043bfbc3-c33b-78b7-e063-6294a90a1a5a2
238910benzocaine 20 % Oral GelPSN0b51b67c-03ac-5730-e063-6394a90a50601
996288HurriCaine 20 % Oral GelPSN0b51b67c-03ac-5730-e063-6394a90a50601
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD0b51b67c-03ac-5730-e063-6394a90a50601
238910benzocaine 0.2 MG/MG Oral GelSCD0b51b67c-03ac-5730-e063-6394a90a50601
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY0b51b67c-03ac-5730-e063-6394a90a50601
996288Hurricaine 0.2 MG/MG Oral GelSY0b51b67c-03ac-5730-e063-6394a90a50601
996288Hurricaine 20 % Dental GelSY0b51b67c-03ac-5730-e063-6394a90a50601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0283-0520-270028305202742.52 g in 1 TUBE (0283-0520-27) 42.52 g2023-08-31NoNoCurrent
0283-0520-29002830520294 SYRINGE, PLASTIC in 1 BOX (0283-0520-29) / 1.2 g in 1 SYRINGE, PLASTIC (0283-0520-44) 2023-03-15NoNoCurrent
0283-0520-34002830520344 SYRINGE, PLASTIC in 1 BOX (0283-0520-34) > 1.5 g in 1 SYRINGE, PLASTIC (0283-0520-43) 2021-01-310000-00-00NoNoCurrent
0283-0520-43002830520431.5 g in 1 SYRINGE, PLASTIC1.5 gHistorical
0283-0520-44002830520441.2 g in 1 SYRINGE, PLASTIC1.2 gHistorical