Home NDC 63868-511 QC Cool and Heat Roll-On
Product NDC 63868-511
11-digit product format 638680511
Labeler code 63868
Product ID 63868-511_295792be-d777-7ef8-e063-6294a90a1e44
Type HUMAN OTC DRUG
Nonproprietary name Menthol 16%
Dosage form LIQUID
Route TOPICAL
Labeler Chain Drug Marketing Association Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-16
Substance MENTHOL
Active strength 16 g/100g
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 QC Cool and Heat Roll-On
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866084 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-511-02 QC Cool and Heat Roll-On 71 g in 1 BOTTLE LIQUID 71 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-511 QC COOL AND HEAT ROLL-ON (MENTHOL 16%) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC] 3 Current NDC, Legacy NDC, 1 package rows 20241217_d35e9dfa-8a28-fdb3-e053-2995a90abc52.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 8 of 156 · 3,115 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 63868-511-02 63868051102 71 g in 1 BOTTLE (63868-511-02) 71 g 2021-12-16 0000-00-00 No No Current