Home NDC 55758-505 Dolodent
Product NDC 55758-505
11-digit product format 557580505
Labeler code 55758
Product ID 55758-505_52bc0c9b-e399-5c55-e063-6294a90aa2f2
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form LIQUID
Route TOPICAL
Labeler Pharmadel LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-14
Substance BENZOCAINE
Active strength 200 mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dolodent
Brand name suffix Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1435490 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-505-01 DolodentMaximum Strength 1 in 1 CARTON LIQUID 1 4 55758-505-01 DolodentMaximum Strength 15 mL in 1 BOTTLE, SPRAY LIQUID 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-505 DOLODENT MAXIMUM STRENGTH (BENZOCAINE) LIQUID [PHARMADEL LLC] 1 Current NDC, 2 package rows 20250521_351ecc2b-cc1a-2bbf-e063-6394a90a5c14.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55758-505-01 55758050501 1 BOTTLE, SPRAY in 1 CARTON (55758-505-01) / 15 mL in 1 BOTTLE, SPRAY 2025-05-14 No No Current