Home NDC 50814-017 Refill 3
Product NDC 50814-017
11-digit product format 508140017
Labeler code 50814
Product ID 50814-017_2cb35d2e-bb1e-6ad6-e063-6294a90ac1c9
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler GFA Production (Xiamen) Co., Ltd.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-08-10
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength .13; .5 g/100g; g/100g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Refill 3
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100g LIDOCAINE HYDROCHLORIDE .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012100 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 50814-017-01 Refill 3 10 in 1 BOX CREAM 10 8 50814-017-01 Refill 3 0.9 g in 1 PACKAGE CREAM 0.9 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50814-017 REFILL 3 (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [GFA PRODUCTION (XIAMEN) CO., LTD.] 8 Current NDC, 2 package rows 20250209_0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa.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 115 · 2,286 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 50814-017-01 50814001701 10 PACKAGE in 1 BOX (50814-017-01) / .9 g in 1 PACKAGE 10 package 2016-08-10 No No Current