hurricaine topical anesthetic

Generic: benzocaine

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

Drug Facts

Product Profile

Brand Name hurricaine topical anesthetic
Generic Name benzocaine
Labeler beutlich pharmaceuticals, llc
Dosage Form GEL
Routes
DENTAL ORAL PERIODONTAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Beutlich Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0283-1016
Product ID 0283-1016_259039d7-ae05-7abc-e063-6294a90af1fd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2016-10-15

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 02831016
Hyphenated Format 0283-1016

Supplemental Identifiers

RxCUI
238910 996288
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 topical anesthetic (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL ORAL PERIODONTAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 60 CUP, UNIT-DOSE in 1 BOX (0283-1016-59) / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45)
source: ndc

Packages (1)

0283-1016-59 60 CUP, UNIT-DOSE in 1 BOX (0283-1016-59) / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (2)

HurriCaine Topical Anesthetic ndc-match (0.9) HurriCaine Topical Anesthetic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL", "ORAL", "PERIODONTAL"], "spl_id": "259039d7-ae05-7abc-e063-6294a90af1fd", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910", "996288"], "spl_set_id": ["0605d5d6-82bd-415e-b5cb-e273f934a4a7"], "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": "60 CUP, UNIT-DOSE in 1 BOX (0283-1016-59)  / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45)", "package_ndc": "0283-1016-59", "marketing_start_date": "20210131"}], "brand_name": "HurriCaine Topical Anesthetic", "product_id": "0283-1016_259039d7-ae05-7abc-e063-6294a90af1fd", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "0283-1016", "generic_name": "BENZOCAINE", "labeler_name": "Beutlich Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HurriCaine", "brand_name_suffix": "Topical Anesthetic", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20161015", "listing_expiration_date": "20261231"}