benzodent

Generic: benzocaine

Labeler: focus consumer healthcare, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name benzodent
Generic Name benzocaine
Labeler focus consumer healthcare, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzocaine .2 g/g

Manufacturer
Focus Consumer Healthcare, LLC

Identifiers & Regulatory

Product NDC 71687-1053
Product ID 71687-1053_32bdc834-3e3d-c53a-e063-6394a90a408c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2017-12-08

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 716871053
Hyphenated Format 71687-1053

Supplemental Identifiers

RxCUI
723562 1112942
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 benzodent (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .2 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (71687-1053-1) / 7 g in 1 TUBE
  • 1 TUBE in 1 CARTON (71687-1053-2) / 28 g in 1 TUBE
source: ndc

Packages (2)

71687-1053-1 1 TUBE in 1 CARTON (71687-1053-1) / 7 g in 1 TUBE 71687-1053-2 1 TUBE in 1 CARTON (71687-1053-2) / 28 g in 1 TUBE

Ingredients (1)

benzocaine (.2 g/g)

Linked Drug Pages (1)

Benzodent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "32bdc834-3e3d-c53a-e063-6394a90a408c", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["723562", "1112942"], "spl_set_id": ["5fdcb871-d387-6352-e053-2991aa0a09da"], "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": ["Focus Consumer Healthcare, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (71687-1053-1)  / 7 g in 1 TUBE", "package_ndc": "71687-1053-1", "marketing_start_date": "20171208"}, {"sample": false, "description": "1 TUBE in 1 CARTON (71687-1053-2)  / 28 g in 1 TUBE", "package_ndc": "71687-1053-2", "marketing_start_date": "20171208"}], "brand_name": "Benzodent", "product_id": "71687-1053_32bdc834-3e3d-c53a-e063-6394a90a408c", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "71687-1053", "generic_name": "Benzocaine", "labeler_name": "Focus Consumer Healthcare, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Benzodent", "active_ingredients": [{"name": "BENZOCAINE", "strength": ".2 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20171208", "listing_expiration_date": "20261231"}