oral gel oral pain relief

Generic: benzocaine benzalkonium chloride

Labeler: savvy care and cosmetics
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name oral gel oral pain relief
Generic Name benzocaine benzalkonium chloride
Labeler savvy care and cosmetics
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzalkonium chloride .1 g/100g, benzocaine 20 g/100g

Manufacturer
Savvy Care and Cosmetics

Identifiers & Regulatory

Product NDC 83650-101
Product ID 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2023-09-22

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 83650101
Hyphenated Format 83650-101

Supplemental Identifiers

RxCUI
1595155
UNII
F5UM2KM3W7 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 oral gel oral pain relief (source: ndc)
Generic Name benzocaine benzalkonium chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .1 g/100g
  • 20 g/100g
source: ndc
Packaging
  • 42.5 g in 1 TUBE (83650-101-01)
source: ndc

Packages (1)

83650-101-01 42.5 g in 1 TUBE (83650-101-01)

Ingredients (2)

benzalkonium chloride (.1 g/100g) benzocaine (20 g/100g)

Linked Drug Pages (1)

Oral Gel Oral Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "299dca27-d254-e6ea-e063-6394a90a4f74", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["F5UM2KM3W7", "U3RSY48JW5"], "rxcui": ["1595155"], "spl_set_id": ["05ede7e4-5a0a-c942-e063-6294a90a8a24"], "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": ["Savvy Care and Cosmetics"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "42.5 g in 1 TUBE (83650-101-01)", "package_ndc": "83650-101-01", "marketing_start_date": "20230922"}], "brand_name": "Oral Gel Oral Pain Relief", "product_id": "83650-101_299dca27-d254-e6ea-e063-6394a90a4f74", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "83650-101", "generic_name": "Benzocaine Benzalkonium Chloride", "labeler_name": "Savvy Care and Cosmetics", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Oral Gel", "brand_name_suffix": "Oral Pain Relief", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": ".1 g/100g"}, {"name": "BENZOCAINE", "strength": "20 g/100g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230922", "listing_expiration_date": "20261231"}