FDA.reportPublic FDA data

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 firm2026-10-23

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
0316-0226-082023-02-13Mineral Ice
0316-0226-082023-02-13Mineral Ice
0316-0226-162023-02-13Mineral Ice
0316-0226-162023-02-13Mineral Ice
0316-0226-352023-02-13Mineral Ice
0316-0226-352023-02-13Mineral Ice
0316-0226-082023-01-30Mineral Ice
0316-0226-082023-01-30Mineral Ice
0316-0226-162023-01-30Mineral Ice
0316-0226-162023-01-30Mineral Ice
0316-0226-352023-01-30Mineral Ice
0316-0226-352023-01-30Mineral Ice

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 83 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYNC PROSYNC RELIEF PRO CREAMiON Pharma, LLC3a3e91d6-732b-dca9-e063-6394a90a06d42025-07-28WarningsExact identifier
application number: M017
Careland Pain ReliefMETHYL SALICYLATE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.83f36771-1033-4fd0-a0e6-82c1dcfedeee2025-07-28WarningsExact identifier
application number: M017
Rite Aid anti-itchHYDROCORTISONERite Aid Corporation2a232dd1-9071-4c55-a7f7-19d8404b99a62025-07-28WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONERITE AID CORPORATION05598255-3e7a-46a5-ae7e-dcfcb616d59d2025-07-28WarningsExact identifier
application number: M017
Inked InspiredLIDOCAINE HCLProdigy Media Inc54fb2860-7e63-4598-953a-170226e613e92025-07-28WarningsExact identifier
application number: M017
Ujhay Hydrocortisone Ointment.UJHAY HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3af59276-8e6a-0603-e063-6394a90a1f9b2025-07-27WarningsExact identifier
application number: M017
SANA SANA Menthol External AnalgesicMENTHOLAlquimia Najulam S de RL de CV8b7edd51-e08a-4e01-9df0-8305ce17b4182025-07-25WarningsExact identifier
application number: M017
Hydrocortisone Intensive Healing FormulaHYDROCORTISONETARGET Corporation682b737f-e453-4079-bf31-47a9485c78972025-07-25WarningsExact identifier
application number: M017
Chigg AwayBENZOCAINEPierson Laboratories, Inc.8372e7c1-f145-4bc5-85ab-cf831abe70ce2025-07-24WarningsExact identifier
application number: M017
Chigg AwayBENZOCAINEPharma Nobis, LLCe42fa1c6-d804-630f-e053-2995a90add6b2025-07-24WarningsExact identifier
application number: M017
Cannarelief 2000mgMENTHOLEarthmed LLC01f810de-52ba-8beb-e063-6394a90a61c02025-07-24WarningsExact identifier
application number: M017
CHING WAN HUNG SOOTHING HERBAL BALMMENTHOLTIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD.ffadc904-8e9d-4cb8-815a-d583bbdb3f0b2025-07-24WarningsExact identifier
application number: M017
PT Elite Premium Pain ReliefCAPSAICIN, MENTHOLPT ELITE PRODUCTS LLCad251821-4c58-425d-bdcb-8dd9bd41b7132025-07-23WarningsExact identifier
application number: M017
Whipped Butter SPF 50ZINC OXIDEBloomeffects, Inc374b62d8-e012-591f-e063-6294a90aef932025-07-23WarningsExact identifier
application number: M017
Game On XtremeMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.5a1b6192-d537-42b3-add8-22c63e7c986c2025-07-23WarningsExact identifier
application number: M017
AMRUTANJAN RELIEF PAIN BALMCAMPHOR , MENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITEDddee6714-8b18-4d87-944b-8467fda22e6b2025-07-23WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.8bb89002-d7a2-4bee-b5a5-1fd1949273ef2025-07-22WarningsExact identifier
application number: M017
Hielo ArdienteMENTHOLMenper Distributors, Inc.97ec516c-d2bc-47ce-82fe-bd68445d95702025-07-22WarningsExact identifier
application number: M017
La Flecha JaponesaMETHYL SALICYLATEMenper Distributors, Inc.08819ad0-97c2-49bd-b923-535b94a271672025-07-22WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMenper Distributors Inc.ad940dc8-9403-44cf-aed3-6e538cbe488b2025-07-22WarningsExact 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