Home NDC 83650-101 Oral Gel
Product NDC 83650-101
11-digit product format 836500101
Labeler code 83650
Product ID 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine Benzalkonium Chloride
Dosage form GEL
Route TOPICAL
Labeler Savvy Care and Cosmetics
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-22
Substance BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength 20; .1 g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Oral Gel
Brand name suffix Oral Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 20 g/100g BENZALKONIUM CHLORIDE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1595155 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 83650-101-01 Oral GelOral Pain Relief 42.5 g in 1 TUBE GEL 42.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83650-101 ORAL GEL ORAL PAIN RELIEF (BENZOCAINE BENZALKONIUM CHLORIDE) GEL [SAVVY CARE AND COSMETICS] 2 Current NDC, 1 package rows 20241222_05ede7e4-5a0a-c942-e063-6294a90a8a24.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 14 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83650-101-01 83650010101 42.5 g in 1 TUBE (83650-101-01) 42.5 g 2023-09-22 No No Current