Home NDC 27854-333 Flanax Back Pain Relief
Product NDC 27854-333
11-digit product format 278540333
Labeler code 27854
Product ID 27854-333_11c5c124-3698-4ff3-b514-203c35325ca3
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form PATCH
Route TOPICAL
Labeler Belmora LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-15
Substance LIDOCAINE
Active strength 4 g/1
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Flanax Back Pain Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737778 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 27854-333-01 Flanax Back Pain Relief 1 in 1 POUCH PATCH 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27854-333 FLANAX BACK PAIN RELIEF (LIDOCAINE) PATCH [BELMORA LLC] 2 Current NDC, Legacy NDC, 1 package rows 20241009_46d33346-e582-4af1-b81a-feca7033dceb.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27854-333-01 27854033301 1 PATCH in 1 POUCH (27854-333-01) 1 patch 2021-12-15 0000-00-00 No No Current