topcare maximum strength

Generic: benzocaine

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare maximum strength
Generic Name benzocaine
Labeler topco associates llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

benzocaine 20 g/100g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-443
Product ID 36800-443_3c30a984-220e-ed07-e063-6394a90ae4d7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

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 36800443
Hyphenated Format 36800-443

Supplemental Identifiers

RxCUI
308657
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 topcare maximum strength (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 g/100g
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58) / 14.17 g in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

36800-443-58 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58) / 14.17 g in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

benzocaine (20 g/100g)

Linked Drug Pages (1)

Topcare Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c30a984-220e-ed07-e063-6394a90ae4d7", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["308657"], "spl_set_id": ["6586fcda-b232-46b4-8461-c0042a4127c6"], "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": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58)  / 14.17 g in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "36800-443-58", "marketing_start_date": "20141001"}], "brand_name": "Topcare Maximum Strength", "product_id": "36800-443_3c30a984-220e-ed07-e063-6394a90ae4d7", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "36800-443", "generic_name": "Benzocaine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "BENZOCAINE", "strength": "20 g/100g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141001", "listing_expiration_date": "20261231"}