Register entryRepackager / relabeller
KOBAYASHI America Manufacturing, LLC
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 26
- Labeller names
- 3
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling1Packaging1Relabelling1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| KOBAYASHI America Manufacturing, LLC | 245 Kraft Drive, Dalton, Georgia (GA) 30721, United States (USA) | Labelling, Packaging, Relabelling, Repackaging | 3003079019079852150 |
Catalogue
Drug listings by form and route
2626 active NDC listings: 26 human otc drug. By marketing category: OTC MONOGRAPH DRUG 22, UNAPPROVED HOMEOPATHIC 3, UNAPPROVED DRUG OTHER 1.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 7 |
| gel | 4 |
| liquid | 4 |
| patch | 2 |
| soap | 2 |
| tablet, chewable | 2 |
| cream | 1 |
| lotion/shampoo | 1 |
| ointment | 1 |
| spray | 1 |
| tablet, coated | 1 |
| Route | NDCs |
|---|---|
| topical | 16 |
| oral | 10 |
| Labeller name on the listing | NDCs |
|---|---|
| kobayashi healthcare international, inc. | 18 |
| kobayashi healthcare international, inc. | 7 |
| kobayashi healthcare international, inc | 1 |
Catalogue
Marketed products
26| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Arthriten Inflammatory Pain Formula | acetaminophen, aspirin, caffeine | tablet, film coated, oral | 52389-237OTC MONOGRAPH DRUG |
| BackAid | acetaminophen, caffeine | tablet, film coated, oral | 52389-253OTC MONOGRAPH DRUG |
| BackAid Max | acetaminophen, pamabrom | tablet, film coated, oral | 52389-153OTC MONOGRAPH DRUG |
| Diurex Max | Pamabrom | tablet, film coated, oral | 52389-249OTC MONOGRAPH DRUG |
| Diurex Ultimate | Caffeine | tablet, film coated, oral | 52389-656OTC MONOGRAPH DRUG |
| Diurex Ultra | Caffeine | tablet, film coated, oral | 52389-155OTC MONOGRAPH DRUG |
| Diurex Water Pills | Caffeine, magnesium salicylate | tablet, coated, oral | 52389-306OTC MONOGRAPH DRUG |
| Fungicure AF Wash | Sepia | soap, topical | 52389-666UNAPPROVED HOMEOPATHIC |
| Fungicure Anti-Fungal Liquid | Tolnaftate | liquid, topical | 52389-298OTC MONOGRAPH DRUG |
| Fungicure Anti-Fungal Wash | Sepia | soap, topical | 52389-226UNAPPROVED HOMEOPATHIC |
| Fungicure Intensive | Clotrimazole | liquid, topical | 52389-600OTC MONOGRAPH DRUG |
| Fungicure Liquid Gel | Clotrimazole | gel, topical | 52389-733OTC MONOGRAPH DRUG |
| Fungicure Night Cream | Clotrimazole | cream, topical | 52389-681OTC MONOGRAPH DRUG |
| Nauzene | Sodium Citrate | tablet, chewable, oral | 52389-242OTC MONOGRAPH DRUG |
| Nauzene Chewables Ginger Honey | Sodium citrate | tablet, chewable, oral | 52389-677OTC MONOGRAPH DRUG |
| Prosacea | Sulphur | gel, topical | 52389-173UNAPPROVED HOMEOPATHIC |
| Psoriasin Deep Moisturizing | Coal Tar | ointment, topical | 52389-752OTC MONOGRAPH DRUG |
| Psoriasin In-Shower Treatment | Coal Tar | lotion/shampoo, topical | 52389-670OTC MONOGRAPH DRUG |
| Uricalm Maximum Strength | Phenazopyridine Hydochloride | tablet, film coated, oral | 52389-241UNAPPROVED DRUG OTHER |
| ZIMS MAX FREEZE | LIDOCAINE HYDROCHLORIDE and MENTHOL, | patch, topical | 54273-012OTC MONOGRAPH DRUG |
| ZIMS MAX FREEZE LEG CRAMP | Menthol | liquid, topical | 54273-011OTC MONOGRAPH DRUG |
| ZIMS MAX FREEZE LEG CRAMPS | CAMPHOR, MENTHOL | patch, topical | 54273-013OTC MONOGRAPH DRUG |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | gel, topical | 54273-006OTC MONOGRAPH DRUG |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | gel, topical | 54273-007OTC MONOGRAPH DRUG |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL | spray, topical | 54273-008OTC MONOGRAPH DRUG |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | liquid, topical | 54273-009OTC MONOGRAPH DRUG |
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Enquiry
Common questions
- Is KOBAYASHI America Manufacturing, LLC FDA approved?
- KOBAYASHI America Manufacturing, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are KOBAYASHI America Manufacturing, LLC's registered sites?
- The FDA register lists Dalton, GA. Registered operations: labelling, packaging, relabelling, repackaging.
- What drugs does KOBAYASHI America Manufacturing, LLC make?
- 26 products are listed under KOBAYASHI America Manufacturing, LLC in the openFDA NDC Directory, most often as tablet, film coated; gel; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.