VAGISTAT 3
Miconazole nitrate
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1450238 | 1450238 | COMBE LABORATORIES, INC. | 1 | N | 2026-01-01 | 200 SHELHOUSE DR. RANTOUL IL US 61866 |
| 2412672 | 2412672 | COMBE INCORPORATED | 1 | N | 2026-01-01 | 1101 Westchester Ave White Plains NY US 10604 |
| 2650087 | 2650087 | COMBE PRODUCTS, INC. | 1 | N | 2026-01-01 | EL DUQUE INDUSTRIAL PARK ROAD 971 STREET A Bo Mariana PR US 00718 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00011509060501 | Vagisil Prohydrate Natural Feel Internal Vaginal Moisturizing Gel - Vagisil Moisturizing Gel is an Over-The-Counter personal lubricant, intended to both moisturize and lubricate and is presented in 8 pre filled applicators of 0.20 oz (5.9 g) each for easy use. The device is sold in a carton. REFERENCE FDA UDI ALTERNATIVE NUMBER: UDI-A160001 | 18004312610 | xxx@xx.xx |
| 10011509060508 | Vagisil - Personal Lubricant | +1(800)431-2610 | XX@xx.xx |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 187541 | 1226965987 | K221036 | Astroglide Warming | NUC | 2022-07-01 |
| 187541 | 1967592712 | K220653 | Astroglide Glycerin & Paraben Free | NUC | 2022-05-06 |
| 187541 | 1884600624 | K220355 | Astroglide Ultra Gentle Gel | NUC | 2022-05-26 |
| 187541 | 1567204752 | K213671 | Astroglide Sensual Strawberry Personal Lubricant | NUC | 2022-03-03 |
| 187541 | 1362013653 | K210242 | Astroglide X Silicone Personal Lubricant | NUC | 2021-04-28 |
| 187541 | 2021214033 | K200114 | Astroglide Organix Liquid | NUC | 2020-10-13 |
| 187541 | 1144081031 | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | NUC | 2017-08-30 |
| 187541 | 1312040873 | K171855 | External Moisturizing Gel | NUC | 2017-07-21 |
| 6846 | 1312040873 | K171855 | External Moisturizing Gel | NUC | 2017-07-21 |
| 187541 | 1315781538 | K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | NUC | 2017-02-10 |
| 187541 | 1057056195 | K150615 | Vaginal Moisturizing Gel | NUC | 2015-05-01 |
| 6846 | 1057056195 | K150615 | Vaginal Moisturizing Gel | NUC | 2015-05-01 |
| 6845 | 1057056195 | K150615 | Vaginal Moisturizing Gel | NUC | 2015-05-01 |
| 187541 | 1757508041 | K041432 | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT | HIS | 2004-11-30 |
| 187541 | 1263232911 | K003867 | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) | NUC | 2001-03-09 |
| 187541 | 1355281890 | ||||
| 187541 | 1919723066 | ||||
| 187541 | 1999686017 | ||||
| 6845 | 1999686017 |
Miconazole nitrate
Tioconazole
Miconazole nitrate
Benzocaine and Resorcinol
pramoxine hydrochloride
pramoxine hydrochloride
Hydrocortisone Acetate
Benzocaine and Resorcinol
Combe Incorporated
COMBE INCORPORATED
COMBE INCORPORATED
COMBE, INC.
COMBE, INC.
COMBE, INC.
COMBE, INC.
2026-01-26
2026-01-26
2016-09-26
2023-10-03
2023-10-03