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 66 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
TONG FENG DING PAIN RELIEF	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	5ef90782-8201-47d1-b57f-f032d4c9b06a	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	1388ab3a-c26f-427d-898d-0d88411a5fba	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Capsaicin Patch Hot	CAPSAICIN	MADISON ONE ACME INC	f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Lung Choy Shung Pain Relief Liquid	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	4842c6ec-7823-4f6b-afc4-258fce2c2391	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	115041ff-5046-4ca4-b54b-5652037e74bd	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEF	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	0f269a41-4b56-4e22-b9cb-17d99bf76a57	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
ZANG HONG HUA PAIN RELIEVING	CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE	MADISON ONE ACME INC	e0a8811c-07cf-4dee-a0e5-13b8af1b27b6	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
NECK AND LUMBAR PAIN RELIEVING BALM	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	d06f0650-a5f6-4bc1-a70b-b0fc16968fa9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
SHU JIN HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	ccb6740d-3399-4a2b-ae65-15ca557ba83b	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Exact identifier application number: M017
HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	65581716-5a2c-4ee8-816d-00caed7b95b4	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
JOSEPHS LION PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
QIAN LI ZHUI FENG PAIN RELIEVING	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	MADISON ONE ACME INC	03a4fb7c-2328-409d-99c8-cbcf2b4a451f	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATED	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	05c6b95a-aeb6-4234-97c7-8d77eccb38d8	2025-11-10	Warnings	Exact identifier application number: M017
HEI GUI PAIN RELIEVING	CAMPHOR AND METHYL SALICYLATE	MADISON ONE ACME INC	4140c404-edab-4923-941d-f74125e943a9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	ddcc814e-fcc4-4232-9ab4-826b8aac35f0	2025-11-10	Warnings, Adverse reactions	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