XEROSTOM
- Product NDC
- 61041-212
- 11-digit product format
- 610410212
- Labeler code
- 61041
- Product ID
- 61041-212_00a25149-f05f-4629-9cad-e44790963fa1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM FLUORIDE
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Bio Cosmetics S L
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-02-06
- Marketing end
- 0000-00-00
- Substance
- SODIUM FLUORIDE
- Active strength
- 2 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 product | product | 61041-212 | D | Discontinued by firm | 2026-10-16 | ||
| excluded product | product | 61041-212 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 61041-212 | 61041-212-01 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 61041-212 | 61041-212-03 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61041-212-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61041-212-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61041-212-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61041-212-03 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61041-212-01 | 61041021201 | 1 TUBE in 1 CARTON (61041-212-01) > 64 g in 1 TUBE | 1 tube | 2013-11-08 | 0000-00-00 | No | No | Current |
| 61041-212-03 | 61041021203 | 6.5 g in 1 PACKET (61041-212-03) | 6.5 g | 2015-02-06 | 0000-00-00 | No | No | Current |