NDC 59316-102
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 | 59316-102_3ce2d09b-f366-6a08-e054-00144ff8d46c |
| NDC | 59316-102 |
| Product Type | Human Otc Drug |
| Proprietary Name | Biofreeze |
| Generic Name | Menthol |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-09-19 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | Performance Health LLC |
| Substance Name | MENTHOL |
| Active Ingredient Strength | 40 mg/mL |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 59316-102-10
5 mL in 1 BOTTLE (59316-102-10)
| Marketing Start Date | 2012-01-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59316-102-25 [59316010225]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
| Marketing End Date | 2021-12-31 |
NDC 59316-102-50 [59316010250]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-20 [59316010220]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-80 [59316010280]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-11-02 |
NDC 59316-102-30 [59316010230]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-98 [59316010298]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-15 [59316010215]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
| Marketing End Date | 2018-12-31 |
NDC 59316-102-16 [59316010216]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-09-19 |
| Marketing End Date | 2020-02-26 |
NDC 59316-102-11 [59316010211]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-12 [59316010212]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-09-19 |
NDC 59316-102-40 [59316010240]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-10 [59316010210]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-01-03 |
NDC 59316-102-28 [59316010228]
BIOFREEZE GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-09-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MENTHOL | 40 mg/mL |
OpenFDA Data
| SPL SET ID: | 83d5c2f2-2413-4d28-83b2-0808d0917b4d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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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