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 |
|---|---|---|---|---|---|---|
| Colgate MaxFresh Clean Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 7cb85fc4-573b-45d7-a430-f2fd17320c43 | 2026-08-26 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 8b210b6c-b712-4f14-906c-306922573a26 | 2026-08-26 | Warnings | M021 |
| Crest Pro-Health Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 59dff762-7f66-8bdc-e063-6294a90a9f18 | 2026-08-25 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Nice-Pak Products, LLC | c71d4064-f938-477b-9346-eb38be65390d | 2026-08-25 | Warnings, Adverse reactions | M021 |
| AIM Whitening with Baking Soda | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0fd0b4-33ba-5764-e054-00144ff88e88 | 2026-08-25 | Warnings | M021 |
| OPTIC WHITE PRO SERIES VIBRANT CLEAN | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | b1ada157-a9a0-4eec-83a2-6e448d7f12dc | 2026-08-21 | Warnings | M021 |
| Therabreath Whitening | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 3ba04b55-38f9-76f3-e063-6394a90a3c03 | 2026-08-21 | Warnings | M021 |
| Therabreath Deep Clean | STANNOUS FLUORIDE | Church & Dwight Co., Inc. | 3c372f26-e0c4-0659-e063-6294a90ae9f9 | 2026-08-21 | Warnings | M021 |
| TheraBreath | POTASSIUM NITRATE, SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 2026-08-21 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Your Military Exchanges | eb95e0ca-a94c-41cb-9f54-6c64ed9a9733 | 2026-08-21 | Warnings, Adverse reactions | M021 |
| Pop On Toothpaste. | POP ON TOOTHPASTE. | POPONSMILES,LLC | 4a0edab5-ae36-91b5-e063-6294a90aa685 | 2026-08-21 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 188dc3ac-64c9-438e-858b-846f725c6ea0 | 2026-08-21 | Warnings | M021 |
| COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT | STANNOUS FLUORIDE | Colgate-Palmolive Company | 178d4535-fa57-4b53-b1f8-5c591f2ea9e7 | 2026-08-21 | Warnings | M021 |
| freshSTART Anticavity fluoride toothpaste. | ANTICAVITY FLUORIDE TOOTHPASTE | Guangzhou Xinuo Technology Co., Ltd. | 596432d5-3541-6dff-e063-6294a90a9d42 | 2026-08-19 | Warnings | M021 |
| Colgate Sensitive ProRelief Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | 8d9d485e-6efb-4bca-a779-9e8b0aeed14c | 2026-08-18 | Warnings | M021 |
| SprinJene Natural | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | e64cecc3-0845-4bdf-a449-d78248791ccf | 2026-08-17 | Warnings | M021 |
| ATOMY ANTICAVITY TOOTH | SODIUM MONOFLUOROPHOSPHATE | ATOMY CO., LTD. | 592caccc-e3a9-9c66-e063-6394a90a26e3 | 2026-08-16 | Warnings | M021 |
| SprinJene Health Boost | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 2026-08-14 | Warnings | M021 |
| SprinJene Fresh Boost | SODIUM FLUORIDE | Health and Natural Beauty USA Corp | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 2026-08-14 | Warnings | M021 |
| SprinJene Natural Sensitivity Relief | SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE | Health and Natural Beauty USA Corp | 32cc5bc2-60c9-4cb4-acde-485ae494aba2 | 2026-08-14 | 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 |