Anticavity Fluoride Rinse
- Product NDC
- 41163-213
- 11-digit product format
- 411630213
- Labeler code
- 41163
- Product ID
- 41163-213_4af77d6f-72cf-9e71-e063-6294a90ab81c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-05-14
- Substance
- SODIUM FLUORIDE
- Active strength
- .2 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 41163-213-44 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 41163-213-44 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 41163-213-44 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 41163-213-44 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 41163-213-44 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 41163-213-44 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 41163-213-44 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anticavity Fluoride Rinse
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .2 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 240698 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e696038c-182e-4325-9b90-87fe498d9f67 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41163-213-44 | 2023-01-20 | C162847 | 48780-1 | 9d75b9cf-ffb9-f424-e053-dadaa90a57ce | Equaline 213.001/213AE rev 2 Anticavity Fluoride Rinse, Mint |
| 41163-213-44 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ffb9-f424-e053-dadaa90a57ce | Equaline 213.001/213AE rev 2 Anticavity Fluoride Rinse, Mint |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41163-213-44 | Anticavity Fluoride Rinse | 532 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 532 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Crest Clean Breath Peppermint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ef07b-ee68-e6ae-e063-6394a90af5e5 | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f20343e-6c03-48e8-e063-6294a90a8cdf | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Smooth Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f2042b4-8eae-5c2c-e063-6394a90a640c | 2026-04-10 | Warnings | M021 |
| Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4146d-6281-fe66-e063-6394a90a32c3 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef5261e-9d2f-ae05-e063-6294a90a489a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f0876d9-41c9-d891-e063-6394a90a1cbd | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Charcoal with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef57a05-b9f5-42f7-e063-6294a90a5d89 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint with Stain Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ee26a82-16fd-f0fb-e063-6394a90a91d1 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Whitening Therapy Deep Clean Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 812c1519-1a4b-2495-e053-2a91aa0a914a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4e7c2-1f58-59fc-e063-6294a90ad43b | 2026-04-08 | Warnings | M021 |
| Anticavity mouth rinse Low-foaming Spearmint | 779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT | Dyson Technology Limited | 4ef669b9-defe-8965-e063-6394a90ab335 | 2026-04-08 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c89efc-5fa0-2a05-e053-2a95a90a7b9c | 2026-04-07 | Warnings | M021 |
| Crest 3D White Advanced Charcoal | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f4eb8111-53da-17ae-e053-2a95a90a1127 | 2026-04-07 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | 35385ada-bd8d-4d38-9587-0256885f749f | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | cf0c8b48-0d1c-406a-a67d-7d16187d38d8 | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Crest 3D White Arctic Fresh | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fa08a877-b9e5-4eba-b832-3a28f4f3f83c | 2026-04-07 | Warnings | M021 |
| Anticavity Fluoride | SODIUM FLUORIDE | Family Dollar (FAMILY WELLNESS) | 63c4c0e9-84b1-4076-bdf4-7e9543b2cf46 | 2026-04-01 | Warnings | M021 |
| CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796 | 2026-04-01 | Warnings | M021 |
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 5f87abb7-0e9d-6369-e053-2a91aa0a2411 | 2026-03-31 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4e544d09-0cf3-f0c7-e063-6394a90a2369 | 2026-03-31 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | PSN | e696038c-182e-4325-9b90-87fe498d9f67 | 8 |
| 240698 | sodium fluoride 0.5 MG/ML Mouthwash | SCD | e696038c-182e-4325-9b90-87fe498d9f67 | 8 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | SY | e696038c-182e-4325-9b90-87fe498d9f67 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41163-213-44 | 41163021344 | 532 mL in 1 BOTTLE, PLASTIC (41163-213-44) | 532 ml | 2009-05-14 | No | No | Current |