NDC 59316-114
Biofreeze
Menthol
Biofreeze is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Performance Health Llc. The primary component is Menthol.
| Product ID | 59316-114_60934241-62c9-0ef7-e053-2991aa0a45dd |
| NDC | 59316-114 |
| Product Type | Human Otc Drug |
| Proprietary Name | Biofreeze |
| Generic Name | Menthol |
| Dosage Form | Spray |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-09-19 |
| Marketing Category | OTC MONOGRAPH N / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | Performance Health LLC |
| Substance Name | MENTHOL |
| Active Ingredient Strength | 105 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 59316-114-10
89 mL in 1 BOTTLE (59316-114-10)
| Marketing Start Date | 2016-09-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59316-114-10 [59316011410]
Biofreeze SPRAY
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-09-19 |
NDC 59316-114-30 [59316011430]
Biofreeze SPRAY
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-02-19 |
NDC 59316-114-50 [59316011450]
Biofreeze SPRAY
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-02-19 |
| Marketing End Date | 2021-12-31 |
NDC 59316-114-25 [59316011425]
Biofreeze SPRAY
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2014-02-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MENTHOL | 105 mg/mL |
OpenFDA Data
| SPL SET ID: | 4c798b06-6ee5-41d1-8a14-f6889512ade3 |
| 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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