NDC 51460-1111
AmerFresh
Sodium Fluoride
AmerFresh is a Oral Gel, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Amercare Products, Inc.. The primary component is Sodium Fluoride.
| Product ID | 51460-1111_f4796a85-7502-4122-92d5-4c8af32d3273 |
| NDC | 51460-1111 |
| Product Type | Human Otc Drug |
| Proprietary Name | AmerFresh |
| Generic Name | Sodium Fluoride |
| Dosage Form | Gel, Dentifrice |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-11-14 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Labeler Name | Amercare Products, Inc. |
| Substance Name | SODIUM FLUORIDE |
| Active Ingredient Strength | 0 g/85g |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 51460-1111-3
17 g in 1 TUBE (51460-1111-3)
| Marketing Start Date | 2012-11-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 51460-1111-6 [51460111106]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
NDC 51460-1111-4 [51460111104]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
NDC 51460-1111-7 [51460111107]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
NDC 51460-1111-1 [51460111101]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
NDC 51460-1111-2 [51460111102]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
NDC 51460-1111-3 [51460111103]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
NDC 51460-1111-5 [51460111105]
AmerFresh GEL, DENTIFRICE
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2012-11-14 |
| Inactivation Date | 2019-11-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .187 g/85g |
OpenFDA Data
| SPL SET ID: | 7d12eab2-ad71-4743-9c47-2f3b3bc2aa81 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "AmerFresh" or generic name "Sodium Fluoride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70766-002 | Amerfresh | Amerfresh |
| 70766-001 | Amerfresh | Amerfresh |
| 70766-003 | Amerfresh | Amerfresh |
| 51460-0502 | Amerfresh | Amerfresh |
| 51460-5000 | Amerfresh | Amerfresh |
| 51460-1112 | AmerFresh | AmerFresh |
| 51460-1113 | AmerFresh | AmerFresh |
| 51460-1111 | AmerFresh | AmerFresh |
| 51460-1114 | AmerFresh | AmerFresh |
| 73398-114 | AMERFRESH | AMERFRESH |
| 0135-0234 | AQUAFRESH | sodium fluoride |
| 0126-0021 | Colgate | SODIUM FLUORIDE |
| 0126-0034 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride | SODIUM FLUORIDE |
| 0126-0032 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride | SODIUM FLUORIDE |
| 0041-1421 | Oral-B | Sodium Fluoride |
| 0126-0131 | Phos-Flur | Sodium Fluoride |
| 0126-0135 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0138 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0139 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0074 | PrevidDent 5000 Booster Plus Spearmint | Sodium Fluoride |
| 0126-0016 | PreviDent | Sodium fluoride |
| 0126-0075 | PreviDent | Sodium fluoride |
| 0126-0076 | PreviDent | Sodium fluoride |
| 0126-0179 | PreviDent | Sodium Fluoride |
| 0126-0286 | PreviDent | Sodium Fluoride |
| 0126-0287 | PreviDent | Sodium Fluoride |
| 0126-0072 | PreviDent 5000 Booster Plus Fruitastic | Sodium Fluoride |
| 0126-0033 | PreviDent Alcohol Free | Sodium Fluoride |
| 0126-0088 | PreviDent Fresh Mint | Sodium Fluoride |
| 0126-0289 | PreviDent OrthoDefense | SODIUM FLUORIDE |
| 0126-0288 | PreviDent Very Berry | Sodium Fluoride |
Trademark Results [AmerFresh]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMERFRESH 87176124 5299447 Live/Registered |
Phoenix Trading, Inc. 2016-09-19 |
 AMERFRESH 76146170 2942343 Dead/Cancelled |
AMERCARE PRODUCTS INC. 2000-10-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.