Home NDC 68229-601 SunBurnt PLUS
Product NDC 68229-601
11-digit product format 682290601
Labeler code 68229
Product ID 68229-601_12128c75-015e-8a72-e063-6394a90ae00a
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form GEL
Route TOPICAL
Labeler Quest Products, LLC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-23
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 SunBurnt PLUS
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 1010077 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 68229-601-01 SunBurnt PLUS 118 mL in 1 TUBE GEL 118 1 68229-601-02 SunBurnt PLUS 1 in 1 CARTON GEL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68229-601 SUNBURNT PLUS (LIDOCAINE HYDROCHLORIDE) GEL [QUEST PRODUCTS, LLC.] 1 Current NDC, 2 package rows 20240224_12128c75-015d-8a72-e063-6394a90ae00a.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 Units Marketing start Sample Exclude flag Status 68229-601-01 68229060101 118 mL in 1 TUBE 118 ml Historical 68229-601-02 68229060102 1 TUBE in 1 CARTON (68229-601-02) / 118 mL in 1 TUBE (68229-601-01) 1 tube 2024-02-23 No No Current