hurricaine

Generic: topical anesthetic

Labeler: beutlich pharmaceuticals llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hurricaine
Generic Name topical anesthetic
Labeler beutlich pharmaceuticals llc
Dosage Form SPRAY
Routes
DENTAL PERIODONTAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Beutlich Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 0283-0610
Product ID 0283-0610_4628591f-110c-f93c-e063-6394a90ab42c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2010-06-15

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02830610
Hyphenated Format 0283-0610

Supplemental Identifiers

RxCUI
360348 808357
UNII
U3RSY48JW5
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hurricaine (source: ndc)
Generic Name topical anesthetic (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL PERIODONTAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 2 APPLICATOR in 1 BOX (0283-0610-11) / .492 g in 1 APPLICATOR (0283-0610-43)
  • 25 APPLICATOR in 1 BOX (0283-0610-26) / .492 g in 1 APPLICATOR (0283-0610-43)
source: ndc

Packages (2)

0283-0610-11 2 APPLICATOR in 1 BOX (0283-0610-11) / .492 g in 1 APPLICATOR (0283-0610-43) 0283-0610-26 25 APPLICATOR in 1 BOX (0283-0610-26) / .492 g in 1 APPLICATOR (0283-0610-43)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (1)

HurriCaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL", "PERIODONTAL"], "spl_id": "4628591f-110c-f93c-e063-6394a90ab42c", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["360348", "808357"], "spl_set_id": ["255fba91-6357-4414-ad23-a18694ef886b"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Beutlich Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 APPLICATOR in 1 BOX (0283-0610-11)  / .492 g in 1 APPLICATOR (0283-0610-43)", "package_ndc": "0283-0610-11", "marketing_start_date": "20160401"}, {"sample": false, "description": "25 APPLICATOR in 1 BOX (0283-0610-26)  / .492 g in 1 APPLICATOR (0283-0610-43)", "package_ndc": "0283-0610-26", "marketing_start_date": "20160401"}], "brand_name": "HurriCaine", "product_id": "0283-0610_4628591f-110c-f93c-e063-6394a90ab42c", "dosage_form": "SPRAY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "0283-0610", "generic_name": "Topical Anesthetic", "labeler_name": "Beutlich Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HurriCaine", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20100615", "listing_expiration_date": "20261231"}