NDC 67676-101
OsmoFlex
Menthol
OsmoFlex is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Sarati International, Inc.. The primary component is Menthol.
| Product ID | 67676-101_bbf16863-b493-4b27-8a56-0c3eeb4e4af9 |
| NDC | 67676-101 |
| Product Type | Human Otc Drug |
| Proprietary Name | OsmoFlex |
| Generic Name | Menthol |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 1993-01-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Labeler Name | Sarati International, Inc. |
| Substance Name | MENTHOL |
| Active Ingredient Strength | 1 g/100g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 67676-101-01
113.4 g in 1 TUBE (67676-101-01)
| Marketing Start Date | 1993-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 67676-101-02 [67676010102]
OsmoFlex CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-16 |
| Marketing End Date | 2016-05-22 |
NDC 67676-101-01 [67676010101]
OsmoFlex CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 1993-01-01 |
NDC 67676-101-04 [67676010104]
OsmoFlex CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-16 |
NDC 67676-101-03 [67676010103]
OsmoFlex CREAM
| Marketing Category | OTC monograph not final |
| Application Number | part348 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-16 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MENTHOL | 1.3 g/100g |
OpenFDA Data
| SPL SET ID: | 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "OsmoFlex" or generic name "Menthol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 67676-101 | OsmoFlex | OsmoFlex |
| 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 [OsmoFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSMOFLEX 85404035 4121867 Live/Registered |
SeaBlue Vitamins, LLC 2011-08-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.