Home NDC 82800-200 Prequel Anti-Itch Solution Medicated Calming
Product NDC 82800-200
11-digit product format 828000200
Labeler code 82800
Product ID 82800-200_4c9bac93-a769-93fb-e063-6294a90ab661
Type HUMAN OTC DRUG
Nonproprietary name Medicated Calming Lotion
Dosage form LOTION
Route TOPICAL
Labeler The Center Brands, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-20
Substance PRAMOXINE HYDROCHLORIDE
Active strength 1 g/100g
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 Prequel Anti-Itch Solution Medicated Calming
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1246075 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 82800-200-01 Prequel Anti-Itch Solution Medicated Calming 400 g in 1 TUBE LOTION 400 3
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 73 of 152 · 3,029 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 82800-200-01 82800020001 400 g in 1 TUBE (82800-200-01) 400 g 2025-10-20 No No Current