astra-dent topical anesthetic gel

Generic: benzocaine

Labeler: zag usa inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name astra-dent topical anesthetic gel
Generic Name benzocaine
Labeler zag usa inc
Dosage Form GEL
Routes
DENTAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Zag Usa Inc

Identifiers & Regulatory

Product NDC 71363-104
Product ID 71363-104_2b48147d-0dc7-c03c-e063-6294a90a9925
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

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 71363104
Hyphenated Format 71363-104

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 astra-dent topical anesthetic gel (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
  • 28 g in 1 JAR (71363-104-30)
source: ndc

Packages (1)

71363-104-30 28 g in 1 JAR (71363-104-30)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (1)

Astra-dent Topical Anesthetic Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2b48147d-0dc7-c03c-e063-6294a90a9925", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910"], "spl_set_id": ["f2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee"], "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": ["Zag Usa Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 g in 1 JAR (71363-104-30)", "package_ndc": "71363-104-30", "marketing_start_date": "20180801"}], "brand_name": "Astra-dent Topical Anesthetic Gel", "product_id": "71363-104_2b48147d-0dc7-c03c-e063-6294a90a9925", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "71363-104", "generic_name": "Benzocaine", "labeler_name": "Zag Usa Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Astra-dent Topical Anesthetic Gel", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}