health-tec topical anesthetic

Generic: benzocaine

Labeler: dental health products, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name health-tec topical anesthetic
Generic Name benzocaine
Labeler dental health products, inc.
Dosage Form GEL
Routes
DENTAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Dental Health Products, Inc.

Identifiers & Regulatory

Product NDC 69634-021
Product ID 69634-021_2b39dbc0-2d0d-0a7f-e063-6394a90add31
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

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 69634021
Hyphenated Format 69634-021

Supplemental Identifiers

RxCUI
238910
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 health-tec topical anesthetic (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 30 g in 1 JAR (69634-021-30)
source: ndc

Packages (1)

69634-021-30 30 g in 1 JAR (69634-021-30)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (1)

Health-Tec Topical Anesthetic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2b39dbc0-2d0d-0a7f-e063-6394a90add31", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910"], "spl_set_id": ["170ce528-7115-463c-b360-1d7a958bbd81"], "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": ["Dental Health Products, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 JAR (69634-021-30)", "package_ndc": "69634-021-30", "marketing_start_date": "20180701"}], "brand_name": "Health-Tec Topical Anesthetic", "product_id": "69634-021_2b39dbc0-2d0d-0a7f-e063-6394a90add31", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "69634-021", "generic_name": "Benzocaine", "labeler_name": "Dental Health Products, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Health-Tec Topical Anesthetic", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}