Home NDC 36800-953 TopCare Everyday After Sun Cooling
Product NDC 36800-953
11-digit product format 368000953
Labeler code 36800
Product ID 36800-953_24882cf3-66aa-4a61-e063-6394a90a63b5
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler TOPCO ASSOCIATES LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-05
Substance LIDOCAINE HYDROCHLORIDE
Active strength 5 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 TopCare Everyday After Sun Cooling
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 5 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 1011849 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 36800-953-80 TopCare Everyday After Sun Cooling 226 g in 1 BOTTLE GEL 226 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-953 TOPCARE EVERYDAY AFTER SUN COOLING (LIDOCAINE HYDROCHLORIDE) GEL [TOPCO ASSOCIATES LLC] 2 Current NDC, Legacy NDC, 1 package rows 20241017_baff7293-e1a3-d1f2-e053-2995a90a93ca.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 109 of 151 · 3,020 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-953-80 36800095380 226 g in 1 BOTTLE (36800-953-80) 226 g 2018-12-05 0000-00-00 No No Current