finafta multioral

Generic: benzocaine

Labeler: dextrum laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name finafta multioral
Generic Name benzocaine
Labeler dextrum laboratories inc.
Dosage Form SPRAY
Routes
ORAL
Active Ingredients

benzocaine 7.5 mg/100mL

Manufacturer
Dextrum Laboratories Inc.

Identifiers & Regulatory

Product NDC 65852-001
Product ID 65852-001_3f7c6100-fd2d-9cd9-e063-6294a90a2486
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2004-09-01

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 65852001
Hyphenated Format 65852-001

Supplemental Identifiers

RxCUI
1110816 1110820
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 finafta multioral (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (65852-001-02) / 59 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

65852-001-02 1 BOTTLE, SPRAY in 1 CARTON (65852-001-02) / 59 mL in 1 BOTTLE, SPRAY

Ingredients (1)

benzocaine (7.5 mg/100mL)

Linked Drug Pages (1)

Finafta MultiOral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f7c6100-fd2d-9cd9-e063-6294a90a2486", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["1110816", "1110820"], "spl_set_id": ["cb027ab8-4175-4cc0-a73e-991dfb113df9"], "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": ["Dextrum Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (65852-001-02)  / 59 mL in 1 BOTTLE, SPRAY", "package_ndc": "65852-001-02", "marketing_start_date": "20040901"}], "brand_name": "Finafta MultiOral", "product_id": "65852-001_3f7c6100-fd2d-9cd9-e063-6294a90a2486", "dosage_form": "SPRAY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "65852-001", "generic_name": "Benzocaine", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Finafta", "brand_name_suffix": "MultiOral", "active_ingredients": [{"name": "BENZOCAINE", "strength": "7.5 mg/100mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040901", "listing_expiration_date": "20261231"}