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 |
|---|---|---|---|---|---|---|
| Walgreens Restore and Defend | STANNOUS FLUORIDE | Walgreens | e808ea4b-9081-085b-e053-2a95a90a4f9b | 2026-06-02 | Warnings | M021 |
| Hello Unicorn Splash unicorn splash anticavity fluoride rinse | SODIUM FLUORIDE | Colgate-Palmolive Company | a1014431-7d23-aaff-6dc7-ab58683d0338 | 2026-06-02 | Warnings | M021 |
| Therabreath Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | feab3d45-ff95-4b32-8258-7d932a7380c9 | 2026-06-01 | Warnings | M021 |
| Orajel Toy Story 5 Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b80947d-f389-2f80-e063-6294a90abd55 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 54113245-0c1e-739e-e063-6294a90aea42 | 2026-06-01 | Warnings | M021 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 545258fd-8179-fffc-e063-6394a90a467f | 2026-06-01 | Warnings | M021 |
| Orajel Paw Patrol | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d87bea-3e99-5d04-e053-2a95a90aaf54 | 2026-06-01 | Warnings | M021 |
| Orajel SuperMario | ANTICAVITY TOOTHPASTE | Church & Dwight Co., Inc. | 27d2f6cb-8661-da9c-e063-6394a90a5bde | 2026-06-01 | Warnings | M021 |
| Orajel KidsToothpaste | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d62125-c2c5-5926-e053-2995a90aaa29 | 2026-06-01 | Warnings | M021 |
| AIM CAVITY PROTECTION Multi Benefit | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0f8a33-0b01-40e2-e054-00144ff88e88 | 2026-06-01 | Warnings | M021 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 560980ea-749f-593d-e063-6394a90a1b9e | 2026-06-01 | Warnings | M021 |
| Colgate Revitalizing White | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | c67223ae-b068-41c5-a15b-7ae9840b93ef | 2026-05-27 | Warnings | M021 |
| Colgate Kids Harry Potter | SODIUM FLUORIDE | Colgate-Palmolive Company | 61c06da4-9f02-4fbc-b80f-1c443e298496 | 2026-05-26 | Warnings | M021 |
| sodium fluoride rinse | SODIUM FLUORIDE RINSE | Rockland Cosmetics, Inc. | 52430b12-4d5f-d1e1-e063-6394a90abd64 | 2026-05-20 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | H E B | d0a52519-3339-40ea-93e5-78f76d348a4d | 2026-05-14 | Warnings, Adverse reactions | M021 |
| Burts Bees Extra White | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c92524fd-8b93-592d-e053-2a95a90a88c6 | 2026-05-13 | Warnings | M021 |
| MIPaste Plus Strawberry | SODIUM FLUORIDE | GC America Inc. | 1b68bd67-65d3-4c64-e054-00144ff8d46c | 2026-05-12 | Warnings | M021 |
| White Glo Purple Color Corrector Fluoride Anticavity | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 6f8b77c3-9833-4c75-b41c-a2bc12616157 | 2026-05-12 | Warnings | M021 |
| botalab HERBAL COMPLETE TOOTH | SODIUM FLUORIDE | KMPHARMACEUTICAL CO., LTD. | 51365ef7-ed94-2650-e063-6394a90ab89e | 2026-05-07 | Warnings | M021 |
| Morning Fresh Mint Toothpaste, with Fluoride | MORNING FRESH MINT TOOTHPASTE, WITH FLUORIDE | Dynarex Corporation | 2a42d8ce-e7f2-caa5-e063-6294a90ac01f | 2026-05-07 | 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 |