Home NDC 67777-013 1168
Product NDC 67777-013
11-digit product format 677770013
Labeler code 67777
Product ID 67777-013_1183a4f5-f876-dfb0-e063-6394a90af35f
Type HUMAN OTC DRUG
Nonproprietary name 1168 Burn Spray
Dosage form SPRAY
Route TOPICAL
Labeler Dynarex Corporation
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-29
Substance LIDOCAINE HYDROCHLORIDE
Active strength .02 mg/mL
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 1168
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE .02 mg/mL
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 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 67777-013-05 1168 24 in 1 CASE SPRAY 24 1 67777-013-06 1168 59.1 mL in 1 BOTTLE, SPRAY SPRAY 59.1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67777-013 1168 (1168 BURN SPRAY) SPRAY [DYNAREX CORPORATION] 1 Current NDC, 2 package rows 20240229_1183a4f5-f875-dfb0-e063-6394a90af35f.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67777-013-05 67777001305 24 BOTTLE, SPRAY in 1 CASE (67777-013-05) / 59.1 mL in 1 BOTTLE, SPRAY (67777-013-06) 2024-02-29 No No Current 67777-013-06 67777001306 59.1 mL in 1 BOTTLE, SPRAY 59.1 ml Historical