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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0316-0226	0316-0226-35	D	Discontinued by firm		2026-10-23

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 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b30076a-0af6-2f74-e053-2a91aa0ae08d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0316-0226-08	2023-02-13	Mineral Ice
0316-0226-08	2023-02-13	Mineral Ice
0316-0226-16	2023-02-13	Mineral Ice
0316-0226-16	2023-02-13	Mineral Ice
0316-0226-35	2023-02-13	Mineral Ice
0316-0226-35	2023-02-13	Mineral Ice
0316-0226-08	2023-01-30	Mineral Ice
0316-0226-08	2023-01-30	Mineral Ice
0316-0226-16	2023-01-30	Mineral Ice
0316-0226-16	2023-01-30	Mineral Ice
0316-0226-35	2023-01-30	Mineral Ice
0316-0226-35	2023-01-30	Mineral Ice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0316-0226-08	GM - Gram	0316-0226	3255328b-3c3f-4a59-b8cf-0a6260a04ff3	1	2019-01-24
0316-0226-16	GM - Gram	0316-0226	a83889a9-604a-4ed1-9019-79339c762047	1	2019-01-24
0316-0226-35	GM - Gram	0316-0226	5f2ef2a1-c39d-4b1d-af51-30d33c3f9ebc	1	2019-01-24

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 79 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALCEMISTE	LIDOCAINE HCL	Price Team Ventures, LLC	4383faaa-49cf-47b7-83a6-c2a94b6ff9b5	2025-09-05	Warnings	Exact identifier application number: M017
Lansinoh Pain Relieving	LIDOCAINE HCL	Lansinoh Laboratories Inc	b7cf1fdb-946d-a4e8-e053-2995a90a26a8	2025-09-05	Warnings	Exact identifier application number: M017
Sumifun PLANTAR RELIEF ROLL -ON	4% LIDOCAINE, 1% MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	3c9ee60b-548a-979f-e063-6394a90a70b0	2025-09-03	Warnings	Exact identifier application number: M017
Meijer Capsaicin Heat Patch	CAPSAICIN	Meijer Distribution	3c465557-0a4f-fb72-e063-6294a90a1ef2	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC Ventures Corp DBA Cryoderm	dd95c682-8ddf-43e7-a277-2fca6ec744cc	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL, CAMPHOR, CAPSAICIN	AHC VENTURES CORP DBA CRY	27679d31-a5f3-417b-b0c5-5f6b001ecff9	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	52fff03e-eba2-4604-a71c-2522468f627b	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	de210c3a-c24e-cefd-e053-2a95a90a93ff	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, CAMPHOR, CAPSAICIN	AHC VENTURES CORP DBA CRY	799751f3-726a-42de-934e-dbc3cd1cb8b8	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	de0c9a73-dbc0-599e-e053-2a95a90a7986	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	90334420-5f81-4284-9a57-42e134ce362f	2025-09-02	Warnings	Exact identifier application number: M017
KNEE PAIN RELIRF Patch	CAMPHOR, MENTHOL	Shenzhen Finona Information Technology Co., Ltd	3db971ef-d7fa-0171-e063-6294a90aa58b	2025-09-01	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Creme	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	300ac57e-844a-4840-b285-41ff5518e6b6	2025-08-29	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Gel	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	30b85890-e72d-4af7-bda9-e7744abc92af	2025-08-29	Warnings	Exact identifier application number: M017
Sumifun Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3d7dc8cc-0680-d94d-e063-6394a90ac8e8	2025-08-29	Warnings	Exact identifier application number: M017
TKTALKER NUMBING	NUMBING	Shenzhen Shandian Jingling Technology Co., Ltd.	3d7e6757-f183-2a68-e063-6294a90ae4ca	2025-08-29	Warnings	Exact identifier application number: M017
PBZ OTC	TRIPELENNAMINE HCL 1%	Kingsway Pharmaceuticals dba NFI, LLC	12f72d74-018f-4bc6-acd4-175ca3af4c6d	2025-08-29	Warnings	Exact identifier application number: M017
else.	LIDOCAINE	Else Co.	3d6c7b10-ed03-bbde-e063-6294a90ae92f	2025-08-28	Warnings	Exact identifier application number: M017
Mountain Ice Pain Relief	MENTHOL	Mountainside Medical Equipment, Inc.	c79fdd91-16f4-4ae0-bee4-d37c05ed2074	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise 4% Lidocaine Cream 2.7 oz	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	f39eb3d0-e153-4f50-85b1-ad5c677d176c	2025-08-28	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311502	menthol 2 % Topical Gel	PSN	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
692869	Mineral Ice 2 % Topical Gel	PSN	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
692869	menthol 0.02 MG/MG Topical Gel [Mineral ice]	SBD	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
311502	menthol 0.02 MG/MG Topical Gel	SCD	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
311502	menthol 2 % Topical Gel	SY	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
311502	menthol 2 % topical stick	SY	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
692869	Mineral ice 0.02 MG/MG Topical Gel	SY	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10
692869	Mineral Ice 2 % Topical Gel	SY	7b30076a-0af6-2f74-e053-2a91aa0ae08d	10

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