Home NDC 85622-521 Lidocaine 4% Patch
Product NDC 85622-521
11-digit product format 856220521
Labeler code 85622
Product ID 85622-521_641b85f3-2442-4302-8a0b-36af5bb2c271
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form PATCH
Route TOPICAL
Labeler Blue Heron Pharmaceuticals LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-11
Substance LIDOCAINE
Active strength 40 mg/g
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 Lidocaine 4% Patch
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 40 mg/g
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.
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85622-521-15 85622052115 15 POUCH in 1 BOX (85622-521-15) / 1 g in 1 POUCH 15 pouch 2026-08-11 No No Current