NDC 70766-003
Amerfresh
Sodium Fluoride
Amerfresh is a Topical Paste in the Human Otc Drug category. It is labeled and distributed by Yangzhou Sion Commodity Co.,ltd. The primary component is Sodium Monofluorophosphate.
| Product ID | 70766-003_80e3ae64-aa0e-cdf5-e053-2a91aa0a5d6f |
| NDC | 70766-003 |
| Product Type | Human Otc Drug |
| Proprietary Name | Amerfresh |
| Generic Name | Sodium Fluoride |
| Dosage Form | Paste |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2016-03-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Labeler Name | Yangzhou SION Commodity Co.,Ltd |
| Substance Name | SODIUM MONOFLUOROPHOSPHATE |
| Active Ingredient Strength | 0 g/100g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 70766-003-01
144 TUBE in 1 BOX (70766-003-01) > 17 g in 1 TUBE
| Marketing Start Date | 2016-05-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70766-003-10 [70766000310]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-18 |
NDC 70766-003-13 [70766000313]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2017-12-18 |
NDC 70766-003-07 [70766000307]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-18 |
NDC 70766-003-06 [70766000306]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-18 |
NDC 70766-003-02 [70766000302]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-25 |
NDC 70766-003-04 [70766000304]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-25 |
NDC 70766-003-05 [70766000305]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-18 |
NDC 70766-003-12 [70766000312]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-18 |
NDC 70766-003-08 [70766000308]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-11-23 |
NDC 70766-003-11 [70766000311]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-06-18 |
NDC 70766-003-01 [70766000301]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-25 |
NDC 70766-003-09 [70766000309]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-11-23 |
NDC 70766-003-03 [70766000303]
Amerfresh PASTE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-05-25 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | .22 g/100g |
OpenFDA Data
| SPL SET ID: | 41f32cae-e80d-2e25-e054-00144ff8d46c |
| Manufacturer | |
| UNII |
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 |
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