Mouth Rinse
- Product NDC
- 36800-001
- 11-digit product format
- 368000001
- Labeler code
- 36800
- Product ID
- 36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium fluoride
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-12-30
- Substance
- SODIUM FLUORIDE
- Active strength
- .1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Mouth Rinse
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1038904 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c640adc0-e178-4b6a-af44-07d2f7da81d3 | 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 |
|---|---|---|---|---|---|---|
| 36800-001-86 | Mouth Rinse | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | 16 |
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 |
|---|---|---|---|---|
| 1038904 | sodium fluoride 0.0221 % (fluoride ion 0.01 % ) Mouthwash | PSN | c640adc0-e178-4b6a-af44-07d2f7da81d3 | 16 |
| 1038904 | sodium fluoride 0.221 MG/ML Mouthwash | SCD | c640adc0-e178-4b6a-af44-07d2f7da81d3 | 16 |
| 1038904 | sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral Rinse | SY | c640adc0-e178-4b6a-af44-07d2f7da81d3 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-001-86 | 36800000186 | 1000 mL in 1 BOTTLE, PLASTIC (36800-001-86) | 1000 ml | 2010-12-30 | 0000-00-00 | No | No | Current |