Home NDC 55319-108 Family Wellness
Product NDC 55319-108
11-digit product format 553190108
Labeler code 55319
Product ID 55319-108_40ab3bb4-cbc0-b9e1-e063-6294a90a5a0f
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine 20%
Dosage form GEL
Route TOPICAL
Labeler FAMILY DOLLAR SERVICES INC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance BENZOCAINE
Active strength .2 g/g
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 Family Wellness
Brand name suffix Oral Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE .2 g/g
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 238910 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-108-14 Family WellnessOral Pain Relief 1 in 1 CARTON GEL 1 3 55319-108-14 Family WellnessOral Pain Relief 14 g in 1 TUBE GEL 14 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-108 FAMILY WELLNESS ORAL PAIN RELIEF (BENZOCAINE 20%) GEL [FAMILY DOLLAR SERVICES INC] 2 Current NDC, 2 package rows 20250112_105d87d6-9147-43d4-e063-6394a90a57ee.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 29 of 40 · 782 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 55319-108-14 55319010814 1 TUBE in 1 CARTON (55319-108-14) / 14 g in 1 TUBE 1 tube 2024-02-01 No No Current