Polar Frost Cold

Product NDC: 67138-533
11-digit product format: 671380533
Labeler code: 67138
Product ID: 67138-533_86239ca0-709d-45e4-97b1-c185dc945efb
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Mettler Electronics Corp.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2002-11-11
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 40 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67138-533		I	Inactivated by FDA	2026-09-14
excluded package	package	67138-533	67138-533-05	I	Inactivated by FDA	2026-09-14
excluded package	package	67138-533	67138-533-15	I	Inactivated by FDA	2026-09-14
excluded package	package	67138-533	67138-533-50	I	Inactivated by FDA	2026-09-14
excluded package	package	67138-533	67138-533-64	I	Inactivated by FDA	2026-09-14
excluded package	package	67138-533	67138-533-75	I	Inactivated by FDA	2026-09-14

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 3 · 132 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67138-533-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67138-533-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67138-533-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67138-533-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67138-533-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67138-533-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67138-533-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67138-533-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67138-533-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67138-533-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67138-533-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67138-533-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67138-533-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67138-533-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67138-533-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67138-533-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67138-533-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67138-533-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67138-533-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67138-533-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67138-533-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67138-533-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67138-533-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67138-533-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67138-533-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67138-533-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67138-533-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67138-533-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67138-533-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67138-533-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67138-533-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67138-533-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67138-533-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67138-533-64	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67138-533-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67138-533-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67138-533-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67138-533-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67138-533-64	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67138-533-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67138-533-75	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67138-533-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67138-533-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67138-533-64	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67138-533-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67138-533-75	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67138-533-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67138-533-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67138-533-64	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67138-533-50	`ad56d346431e…`	`cc804d4bbf1e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67138-533-05	Polar ® Frost Cold Gel
67138-533-15	Polar ® Frost Cold Gel
67138-533-50	Polar ® Frost Cold Gel
67138-533-64	Polar ® Frost Cold Gel
67138-533-75	Polar ® Frost Cold Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67138-533-05	Polar Frost Cold	5.43 mL in 1 POUCH	GEL	5.43	1
67138-533-15	Polar Frost Cold	150 mL in 1 TUBE	GEL	150	1
67138-533-50	Polar Frost Cold	500 mL in 1 BOTTLE, PUMP	GEL	500	1
67138-533-64	Polar Frost Cold	3785 mL in 1 CANISTER	GEL	3785	1
67138-533-75	Polar Frost Cold	75 mL in 1 BOTTLE, WITH APPLICATOR	GEL	75	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67138-533-15	ML - Milliliter	67138-533	cbce290f-a45a-47e3-80bd-c4ef3f5682d7	1	2014-06-03
67138-533-75	ML - Milliliter	67138-533	52bdac84-ce8a-481a-934e-4177a44268f0	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	4Q93RCW27E	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Eucalyptus Oil	INACTIVE INGREDIENT	2R04ONI662	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67138-533	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1	Legacy NDC, 5 package rows	20140520_35fe8a89-e89a-4e1e-bc89-a445e7bc0d44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1
1089083	POLAR FROST 4 % Topical Gel	PSN	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1
1089083	menthol 0.04 MG/MG Topical Gel [Polar Frost]	SBD	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1
415974	menthol 0.04 MG/MG Topical Gel	SCD	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1
415974	menthol 4 % Topical Gel	SY	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1
1089083	Polar Frost 0.04 MG/MG Topical Gel	SY	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1
1089083	Polar Frost 4 % Topical Gel	SY	35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67138-533-05	67138053305	5.43 mL in 1 POUCH	5.43 ml	Historical
67138-533-15	67138053315	150 mL in 1 TUBE	150 ml	Historical
67138-533-50	67138053350	500 mL in 1 BOTTLE, PUMP	500 ml	Historical
67138-533-64	67138053364	3785 mL in 1 CANISTER	3785 ml	Historical
67138-533-75	67138053375	75 mL in 1 BOTTLE, WITH APPLICATOR	75 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Polar ® Frost Cold Gel	Mettler Electronics Corp. \| Niva Medical Oy	2014-05-16	HUMAN OTC DRUG LABEL	1