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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0316-02260316-0226-35DDiscontinued by firm2026-10-27

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-02260316-0226-35DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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
IngredientStrength
MENTHOL20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311502Internal RxNorm lookup
692869Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b30076a-0af6-2f74-e053-2a91aa0ae08dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0226-08Mineral IcePain Relieving226.8 g in 1 JARGEL226.810
0316-0226-16Mineral IcePain Relieving453.6 g in 1 JARGEL453.610
0316-0226-35Mineral IcePain Relieving99.2 g in 1 JARGEL99.210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0226-08GM - Gram0316-02263255328b-3c3f-4a59-b8cf-0a6260a04ff312019-01-24
0316-0226-16GM - Gram0316-0226a83889a9-604a-4ed1-9019-79339c76204712019-01-24
0316-0226-35GM - Gram0316-02265f2ef2a1-c39d-4b1d-af51-30d33c3f9ebc12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0226MINERAL ICE PAIN RELIEVING (MENTHOL) GEL [CROWN LABORATORIES]8Current NDC, Legacy NDC, 3 package rows20231118_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 100 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Soothing Aloe Itch ReliefHYDROCORTISONEChattem, Inc.1962abb3-6ca7-4934-9efe-20287b1c2a5b2025-02-01WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLCd4276749-eeff-28f7-e053-2a95a90a593d2025-01-31WarningsExact identifier
application number: M017
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
application number: M017
Maximum Strength Blue Emu Pain Relief Blu EmuTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC5e02b820-e53a-42cb-abdb-2925617c29ca2025-01-31WarningsExact identifier
application number: M017
Sunset Novelties HerquakeNUMBING LUBRICANTSUNSET INTIMATES GROUP INC2ceeca3e-9197-9166-e063-6394a90ae9082025-01-30WarningsExact identifier
application number: M017
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN7b30076a-0af6-2f74-e053-2a91aa0ae08d10
692869Mineral Ice 2 % Topical GelPSN7b30076a-0af6-2f74-e053-2a91aa0ae08d10
692869menthol 0.02 MG/MG Topical Gel [Mineral ice]SBD7b30076a-0af6-2f74-e053-2a91aa0ae08d10
311502menthol 0.02 MG/MG Topical GelSCD7b30076a-0af6-2f74-e053-2a91aa0ae08d10
311502menthol 2 % Topical GelSY7b30076a-0af6-2f74-e053-2a91aa0ae08d10
311502menthol 2 % topical stickSY7b30076a-0af6-2f74-e053-2a91aa0ae08d10
692869Mineral ice 0.02 MG/MG Topical GelSY7b30076a-0af6-2f74-e053-2a91aa0ae08d10
692869Mineral Ice 2 % Topical GelSY7b30076a-0af6-2f74-e053-2a91aa0ae08d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0226-0800316022608226.8 g in 1 JAR (0316-0226-08) 226.8 g2018-12-010000-00-00NoNoCurrent
0316-0226-1600316022616453.6 g in 1 JAR (0316-0226-16) 453.6 g2018-12-010000-00-00NoNoCurrent
0316-0226-350031602263599.2 g in 1 JAR (0316-0226-35) 99.2 g2018-12-010000-00-00NoNoCurrent