ACT Restoring Anticavity Fluoride Mint Burst
- Product NDC
- 41167-0979
- 11-digit product format
- 411670979
- Labeler code
- 41167
- Product ID
- 41167-0979_c8d906b9-c4c5-425f-8955-e3b451311e74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium fluoride
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Chattem, Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-12-16
- Substance
- SODIUM FLUORIDE
- Active strength
- .5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 41167-0979 | 41167-0979-0 | 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 41167-0979 | 41167-0979-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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
- ACT Restoring Anticavity Fluoride Mint Burst
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a38363e6-7105-4663-95a0-09ecb2948f83 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41167-0979-0 | ACT Restoring Anticavity Fluoride Mint Burst | 532 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 532 | 8 | |
| 41167-0979-1 | ACT Restoring Anticavity Fluoride Mint Burst | 30 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 30 | 8 | |
| 41167-0979-3 | ACT Restoring Anticavity Fluoride Mint Burst | 88 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 88 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41167-0979 | ACT RESTORING ANTICAVITY FLUORIDE MINT BURST (SODIUM FLUORIDE) MOUTHWASH [CHATTEM, INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250214_a38363e6-7105-4663-95a0-09ecb2948f83.zip |
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 |
|---|---|---|---|---|
| 656809 | ACT 0.05 % (fluoride ion 0.02 % ) Mouthwash | PSN | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | PSN | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
| 656809 | sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse] | SBD | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
| 240698 | sodium fluoride 0.5 MG/ML Mouthwash | SCD | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
| 656809 | ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) Mouthwash | SY | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
| 656809 | ACT Fluoride Rinse 0.5 MG/ML Mouthwash | SY | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | SY | a38363e6-7105-4663-95a0-09ecb2948f83 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41167-0979-0 | 41167097900 | 532 mL in 1 BOTTLE, PLASTIC (41167-0979-0) | 532 ml | 2015-12-16 | 0000-00-00 | No | No | Current |
| 41167-0979-1 | 41167097901 | 30 mL in 1 BOTTLE, PLASTIC (41167-0979-1) | 30 ml | 2015-12-16 | 0000-00-00 | No | No | Current |
| 41167-0979-3 | 41167097903 | 88 mL in 1 BOTTLE, PLASTIC (41167-0979-3) | 88 ml | 2015-12-16 | 0000-00-00 | No | No | Current |