Home NDC 0316-0226 Mineral Ice
Product NDC 0316-0226
11-digit product format 003160226
Labeler code 0316
Product ID 0316-0226_4833e9dd-2f42-f6d5-e063-6394a90a1b0a
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Crown Laboratories
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-11-01
Substance MENTHOL
Active strength 20 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0316-0226 0316-0226-35 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 Mineral Ice
Brand name suffix Pain Relieving
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 20 mg/g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311502 Internal RxNorm lookup 692869 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-0226-08 Mineral IcePain Relieving 226.8 g in 1 JAR GEL 226.8 10 0316-0226-16 Mineral IcePain Relieving 453.6 g in 1 JAR GEL 453.6 10 0316-0226-35 Mineral IcePain Relieving 99.2 g in 1 JAR GEL 99.2 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0226 MINERAL ICE PAIN RELIEVING (MENTHOL) GEL [CROWN LABORATORIES] 8 Current NDC, Legacy NDC, 3 package rows 20231118_7b30076a-0af6-2f74-e053-2a91aa0ae08d.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 Marketing end Sample Exclude flag Status 0316-0226-08 00316022608 226.8 g in 1 JAR (0316-0226-08) 226.8 g 2018-12-01 0000-00-00 No No Current 0316-0226-16 00316022616 453.6 g in 1 JAR (0316-0226-16) 453.6 g 2018-12-01 0000-00-00 No No Current 0316-0226-35 00316022635 99.2 g in 1 JAR (0316-0226-35) 99.2 g 2018-12-01 0000-00-00 No No Current