Home NDC 85638-005 Ocean Potion Suncare Ice Plus Pain Relieving Soothing
Product NDC 85638-005
11-digit product format 856380005
Labeler code 85638
Product ID 85638-005_3c69654c-cba7-dfef-e063-6394a90ad479
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form GEL
Route TOPICAL
Labeler GNL BRANDS INTERNATIONAL, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-19
Substance LIDOCAINE HYDROCHLORIDE
Active strength 8 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 Ocean Potion Suncare Ice Plus Pain Relieving Soothing
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 8 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 1098616 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 85638-005-55 Ocean Potion Suncare Ice Plus Pain Relieving Soothing 243 g in 1 BOTTLE GEL 243 1
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 48 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 85638-005-55 85638000555 243 g in 1 BOTTLE (85638-005-55) 243 g 2025-02-19 No No Current