Amerfresh
- Product NDC
- 70766-003
- Requested package NDC
- 70766-003-12
- 11-digit product format
- 707660003
- Labeler code
- 70766
- Product ID
- 70766-003_d332a469-d257-e8a3-e053-2995a90a42e0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- PASTE
- Route
- TOPICAL
- Labeler
- Yangzhou SION Commodity Co.,Ltd
- Application
- part356
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-03-01
- Marketing end
- 0000-00-00
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 0 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70766-003 | 70766-003-12 | I | Inactivated by FDA | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70766-003-01 | Amerfresh | 17 g in 1 TUBE | PASTE | 17 | 10 | |
| 70766-003-01 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-02 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-02 | Amerfresh | 24 g in 1 TUBE | PASTE | 24 | 10 | |
| 70766-003-03 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-03 | Amerfresh | 43 g in 1 TUBE | PASTE | 43 | 10 | |
| 70766-003-04 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-04 | Amerfresh | 78 g in 1 TUBE | PASTE | 78 | 10 | |
| 70766-003-05 | Amerfresh | 85 g in 1 TUBE | PASTE | 85 | 10 | |
| 70766-003-05 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-06 | Amerfresh | 142 g in 1 TUBE | PASTE | 142 | 10 | |
| 70766-003-06 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-07 | Amerfresh | 7 g in 1 BAG | PASTE | 7 | 10 | |
| 70766-003-07 | Amerfresh | 1000 in 1 BOX | PASTE | 1000 | 10 | |
| 70766-003-08 | Amerfresh | 5 in 1 CARTON | PASTE | 5 | 10 | |
| 70766-003-08 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-09 | Amerfresh | 5 in 1 CARTON | PASTE | 5 | 10 | |
| 70766-003-09 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-10 | Amerfresh | 7.1 g in 1 BAG | PASTE | 7.1 | 10 | |
| 70766-003-10 | Amerfresh | 1000 in 1 BOX | PASTE | 1000 | 10 | |
| 70766-003-11 | Amerfresh | 72 in 1 BOX | PASTE | 72 | 10 | |
| 70766-003-11 | Amerfresh | 142 g in 1 TUBE | PASTE | 142 | 10 | |
| 70766-003-12 | Amerfresh | 181 g in 1 TUBE | PASTE | 181 | 10 | |
| 70766-003-12 | Amerfresh | 72 in 1 BOX | PASTE | 72 | 10 | |
| 70766-003-13 | Amerfresh | 125 in 1 BOX | PASTE | 125 | 10 | |
| 70766-003-13 | Amerfresh | 4 in 1 CARTON | PASTE | 4 | 10 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70766-003-12 | 70766000312 | 72 TUBE in 1 BOX (70766-003-12) > 181 g in 1 TUBE | 72 tube | 2016-06-18 | 0000-00-00 | No | No | Current |