Home NDC 0924-5004 First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel
Product NDC 0924-5004
11-digit product format 009245004
Labeler code 0924
Product ID 0924-5004_5258cc02-81e4-3363-e063-6294a90a82e5
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form GEL
Route TOPICAL
Labeler Acme United Corporation
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 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 First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 mg/g
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 1011852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0924-5004-00 00924500400 3.5 g in 1 PACKET (0924-5004-00) 3.5 g 2026-06-01 No No Current 0924-5004-01 00924500401 6 PACKET in 1 BOX (0924-5004-01) / 3.5 g in 1 PACKET (0924-5004-00) 6 packet 2026-06-01 No No Current 0924-5004-03 00924500403 25 PACKET in 1 BOX (0924-5004-03) / 3.5 g in 1 PACKET (0924-5004-00) 25 packet 2026-06-01 No No Current 0924-5004-17 00924500417 5 PACKET in 1 BOX (0924-5004-17) / 3.5 g in 1 PACKET (0924-5004-00) 5 packet 2026-06-01 No No Current