dolodent maximum strength

Generic: benzocaine

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dolodent maximum strength
Generic Name benzocaine
Labeler pharmadel llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzocaine 200 mg/mL

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-505
Product ID 55758-505_452696f7-00c0-8773-e063-6294a90ae5d1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Marketing Start 2025-05-14
Marketing End 2027-06-01

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 55758505
Hyphenated Format 55758-505

Supplemental Identifiers

RxCUI
1435490
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 dolodent maximum strength (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (55758-505-01) / 15 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

55758-505-01 1 BOTTLE, SPRAY in 1 CARTON (55758-505-01) / 15 mL in 1 BOTTLE, SPRAY

Ingredients (1)

benzocaine (200 mg/mL)

Linked Drug Pages (1)

Dolodent Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "452696f7-00c0-8773-e063-6294a90ae5d1", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["1435490"], "spl_set_id": ["351ecc2b-cc1a-2bbf-e063-6394a90a5c14"], "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": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (55758-505-01)  / 15 mL in 1 BOTTLE, SPRAY", "package_ndc": "55758-505-01", "marketing_end_date": "20270601", "marketing_start_date": "20250514"}], "brand_name": "Dolodent Maximum Strength", "product_id": "55758-505_452696f7-00c0-8773-e063-6294a90ae5d1", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "55758-505", "generic_name": "Benzocaine", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dolodent", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270601", "marketing_start_date": "20250514"}