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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67138-533-05	2019-11-27	C162847	48780-1	9855e2a2-4a4f-60a7-e053-dbdaa90a05bd	Polar ® Frost Cold Gel
67138-533-15	2019-11-27	C162847	48780-1	9855e2a2-4a4f-60a7-e053-dbdaa90a05bd	Polar ® Frost Cold Gel
67138-533-50	2019-11-27	C162847	48780-1	9855e2a2-4a4f-60a7-e053-dbdaa90a05bd	Polar ® Frost Cold Gel
67138-533-64	2019-11-27	C162847	48780-1	9855e2a2-4a4f-60a7-e053-dbdaa90a05bd	Polar ® Frost Cold Gel
67138-533-75	2019-11-27	C162847	48780-1	9855e2a2-4a4f-60a7-e053-dbdaa90a05bd	Polar ® Frost Cold Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	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	Uploaded
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