Lidocaine 4% Patch

Product NDC
85622-522
11-digit product format
856220522
Labeler code
85622
Product ID
85622-522_2bb5ead3-1eee-4033-8ca7-65486c09dc90
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
2026-09-14
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
IngredientStrength
LIDOCAINE40 mg/g

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85622-522-308562205223030 POUCH in 1 BOX (85622-522-30) / 1 g in 1 POUCH30 pouch2026-09-14NoNoCurrent