benzo-jel

Generic: benzocaine

Labeler: henry schein inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name benzo-jel
Generic Name benzocaine
Labeler henry schein inc.
Dosage Form GEL
Routes
DENTAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Henry Schein Inc.

Identifiers & Regulatory

Product NDC 0404-0038
Product ID 0404-0038_2acffbe1-20a7-e2ac-e063-6294a90a5227
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2016-05-01

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 04040038
Hyphenated Format 0404-0038

Supplemental Identifiers

RxCUI
238910 1053444
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 benzo-jel (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 (0404-0038-30)
source: ndc

Packages (1)

0404-0038-30 30 g in 1 JAR (0404-0038-30)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (1)

Benzo-Jel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2acffbe1-20a7-e2ac-e063-6294a90a5227", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910", "1053444"], "spl_set_id": ["c9b584d9-7407-445a-b084-926250af9f8e"], "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": ["Henry Schein Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 JAR (0404-0038-30)", "package_ndc": "0404-0038-30", "marketing_start_date": "20180601"}], "brand_name": "Benzo-Jel", "product_id": "0404-0038_2acffbe1-20a7-e2ac-e063-6294a90a5227", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "0404-0038", "generic_name": "Benzocaine", "labeler_name": "Henry Schein Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Benzo-Jel", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160501", "listing_expiration_date": "20261231"}