topcare oral pain relief 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 oral pain relief maximum strength
Generic Name benzocaine
Labeler topco associates llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzocaine 20 g/100g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-512
Product ID 36800-512_437fcc59-02bc-7d8c-e063-6394a90af1c0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2019-03-05

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 36800512
Hyphenated Format 36800-512

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 topcare oral pain relief maximum strength (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-512-29) / 14 g in 1 TUBE
source: ndc

Packages (1)

36800-512-29 1 TUBE in 1 CARTON (36800-512-29) / 14 g in 1 TUBE

Ingredients (1)

benzocaine (20 g/100g)

Linked Drug Pages (1)

TopCare Oral Pain Relief Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "437fcc59-02bc-7d8c-e063-6394a90af1c0", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910"], "spl_set_id": ["835fb6ac-dbb7-5566-e053-2991aa0af5e2"], "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 TUBE in 1 CARTON (36800-512-29)  / 14 g in 1 TUBE", "package_ndc": "36800-512-29", "marketing_start_date": "20190305"}], "brand_name": "TopCare Oral Pain Relief Maximum Strength", "product_id": "36800-512_437fcc59-02bc-7d8c-e063-6394a90af1c0", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "36800-512", "generic_name": "Benzocaine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Oral Pain Relief", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "BENZOCAINE", "strength": "20 g/100g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190305", "listing_expiration_date": "20261231"}