NDC 71718-333
BIOTEMPER
Menthol
BIOTEMPER is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Scientific Solutions Global, Llc. The primary component is Menthol, Unspecified Form.
| Product ID | 71718-333_158b958a-1a99-4f82-931b-c5c83e320ad2 |
| NDC | 71718-333 |
| Product Type | Human Otc Drug |
| Proprietary Name | BIOTEMPER |
| Generic Name | Menthol |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2017-09-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | Scientific Solutions Global, LLC |
| Substance Name | MENTHOL, UNSPECIFIED FORM |
| Active Ingredient Strength | 10 g/100mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 71718-333-01
118 mL in 1 JAR (71718-333-01)
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 71718-333-15 [71718033315]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-07 [71718033307]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-11 [71718033311]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-04 [71718033304]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-09 [71718033309]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-02 [71718033302]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-05 [71718033305]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-01 [71718033301]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 71718-333-13 [71718033313]
BIOTEMPER GEL
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 10 g/100mL |
OpenFDA Data
| SPL SET ID: | 667fb0b9-6095-4c6c-8731-a4f888951ecc |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "BIOTEMPER" or generic name "Menthol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70744-516 | Biotemper | Biotemper |
| 71718-333 | BIOTEMPER | BIOTEMPER |
| 71718-111 | BioTemper | BioTemper |
| 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 [BIOTEMPER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOTEMPER 87138361 5166067 Live/Registered |
SCIENTIFIC SOLUTIONS GLOBAL LLC 2016-08-15 |
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