Home NDC 69452-393 pain relief roll-on
Product NDC 69452-393
11-digit product format 694520393
Labeler code 69452
Product ID 69452-393_29f92d33-ff52-1181-e063-6394a90a6211
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form LIQUID
Route TOPICAL
Labeler Bionpharma Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-20
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100mL
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 pain relief roll-on
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1987647 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 69452-393-63 pain relief roll-on 74 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 74 2 69452-393-63 pain relief roll-on 1 in 1 CARTON LIQUID 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-393 PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [BIONPHARMA INC.] 2 Current NDC, 2 package rows 20241225_f607b6dc-8d13-604a-e053-2995a90a59ab.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 Marketing start Sample Exclude flag Status 69452-393-63 69452039363 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69452-393-63) / 74 mL in 1 BOTTLE, WITH APPLICATOR 2023-02-20 No No Current