NDC 59316-101
Biofreeze
Menthol
Biofreeze is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Performance Health Llc.. The primary component is Menthol.
| Product ID | 59316-101_606234a7-6409-61f2-e053-2991aa0ae3d1 |
| NDC | 59316-101 |
| Product Type | Human Otc Drug |
| Proprietary Name | Biofreeze |
| Generic Name | Menthol |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-08-25 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | Performance Health LLC. |
| Substance Name | MENTHOL |
| Active Ingredient Strength | 35 mg/mL |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 59316-101-10
5 mL in 1 PACKET (59316-101-10)
| Marketing Start Date | 2016-08-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59316-101-20 [59316010120]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-12-30 |
NDC 59316-101-15 [59316010115]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-08-25 |
NDC 59316-101-30 [59316010130]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-12-30 |
NDC 59316-101-12 [59316010112]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-08-25 |
NDC 59316-101-00 [59316010100]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-06-30 |
| Marketing End Date | 2010-11-03 |
NDC 59316-101-11 [59316010111]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-08-25 |
NDC 59316-101-21 [59316010121]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2018-12-31 |
NDC 59316-101-25 [59316010125]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-12-01 |
NDC 59316-101-40 [59316010140]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-12-30 |
NDC 59316-101-10 [59316010110]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-08-25 |
NDC 59316-101-13 [59316010113]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-08-25 |
NDC 59316-101-50 [59316010150]
Biofreeze GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2009-12-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MENTHOL | 35 mg/mL |
OpenFDA Data
| SPL SET ID: | 684faf63-5e44-4471-8384-e8fa7c0d842a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "Biofreeze" or generic name "Menthol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68788-6457 | Biofreeze | Biofreeze |
| 59316-102 | BIOFREEZE | BIOFREEZE |
| 59316-993 | Biofreeze | Biofreeze |
| 59316-101 | Biofreeze | Biofreeze |
| 59316-104 | Biofreeze | Biofreeze |
| 59316-114 | Biofreeze | Biofreeze |
| 59316-869 | Biofreeze | Biofreeze |
| 0363-1071 | Cherry Cough Drop | Menthol |
| 0363-1086 | Cherry Cough Drops | Menthol |
| 0363-0150 | Cool n Heat Patch for Arm, Neck and Leg | Menthol |
| 0363-0152 | Cool n Heat Patch for Back | Menthol |
| 0363-1072 | Honey Lemon Cough Drop | Menthol |
| 0363-1087 | Honey Lemon Cough Drop | Menthol |
| 0219-0203 | Humphreys Bendito Alcoholado | menthol |
| 0363-1070 | Menthol Cough Drop | menthol |
| 0363-1084 | Menthol Cough Drop | menthol |
| 0067-2067 | Mineral Ice | Menthol |
| 0316-0226 | Mineral Ice | Menthol |
| 0316-0290 | Mineral Ice Quick Dry Foam | Menthol |
| 0363-0151 | Pain Relieving Patch | Menthol |
| 0363-1077 | SF Honey Lemon Cough Drop | Menthol |
| 0363-1085 | SF Menthol Cough Drop | Menthol |
| 0363-0043 | Studio 35 Medicated Body | Menthol |
| 0363-0864 | Walgreens Cold Pain Relief | MENTHOL |
| 0363-0874 | Walgreens Cold Pain Relief | MENTHOL |
| 0363-0966 | Walgreens Sunburn Relief | Menthol |
Trademark Results [Biofreeze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOFREEZE 98087578 not registered Live/Pending |
Reckitt Health Pain (US) LLC 2023-07-17 |
 BIOFREEZE 79064496 3689666 Dead/Cancelled |
Liebherr-International AG 2008-12-19 |
 BIOFREEZE 74316856 1774041 Live/Registered |
HYGENIC INTANGIBLE PROPERTY HOLDING CO. 1992-09-24 |
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