Fluoride Bits
- Product NDC
- 82976-101
- 11-digit product format
- 829760101
- Labeler code
- 82976
- Product ID
- 82976-101_28f176f5-cbbc-b69a-e063-6394a90aa893
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Monofluorophosphate 0.76%
- Dosage form
- TABLET
- Route
- DENTAL
- Labeler
- The Kind Lab, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-19
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- .76 g/1001
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Fluoride Bits
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | .76 g/1001 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C810JCZ56Q | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fa433031-7376-0e5b-e053-6394a90a5f75 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82976-101-00 | Fluoride Bits | 124 in 1 POUCH | TABLET | 124 | 3 |
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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb2 | 2025-12-17 | Warnings | M022 |
| Sore Throat | PHENOL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 9128d59c-6fa9-4358-865a-802257a9bd25 | 2025-12-16 | Warnings | M022 |
| S.T.37 | HEXYLRESORCINOL | NUMARK BRANDS, INC | 7d7acca2-aa8a-5272-e813-faab039cc798 | 2025-12-15 | Warnings | M022 |
| Esunix Oral Bacteriostatic Gel | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999851ac-925c-7d1f-e053-2a95a90a240b | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For Toothache and Gum | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99a2b061-0875-59a4-e053-2995a90ab373 | 2025-12-12 | Warnings | M022 |
| Orajel Antiseptic Rinse For All Mouth Sores | HYDROGEN PEROXIDE AND MENTHOL | Church & Dwight Co., Inc. | 06188d36-0d60-6ae6-e054-00144ff8d46c | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For All Mouth Sores | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99b589ac-9833-fb60-e053-2995a90a0935 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum, Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999aa7b9-bf9e-9285-e053-2a95a90a345b | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated PM For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999cff2b-c23e-5abe-e053-2a95a90a7569 | 2025-12-12 | Warnings | M022 |
| Vicks Formula 44 Cough Drops | MENTHOL | The Procter & Gamble Manufacturing Company | bb9e483e-095d-8a42-e053-2a95a90ad8d6 | 2025-12-12 | Warnings | M022 |
| Benzoin Compound Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | a893a232-2ea8-4e0d-8cbf-7f5040b3be2e | 2025-12-11 | Warnings | M022 |
| Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 456d45e8-bf6d-31c4-e063-6394a90a5c00 | 2025-12-10 | Warnings | M022 |
| Oral pain relief | BENZOCAINE | ALAINA HEALTHCARE PRIVATE LIMITED | d98c1b2f-fe75-4d52-b082-1abb7628c59e | 2025-12-09 | Warnings | M022 |
| HEB Sensitive Extra Whitening Twin | SODIUM FLUORIDE | HEB | 41d5ae3e-51c1-263b-e063-6394a90a3312 | 2025-12-08 | Warnings | M022 |
| CankerMelts | BENZOCAINE | Quest Products, LLC | 070dae82-14c2-66d2-e063-6394a90ab259 | 2025-12-04 | Warnings | M022 |
| Sore Throat ReadyInCase | PHENOL | P & L Development, LLC | 2fb3d17e-8ca3-4edb-8b82-4b484f42616e | 2025-12-03 | Warnings | M022 |
| Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 44f2b66a-26ae-1044-e063-6394a90a9ab6 | 2025-12-02 | Warnings | M022 |
| Sensodyne Fresh Clean | STANNOUS FLUORIDE | Haleon US Holdings LLC | 2d433ac1-3ddf-a2f4-e063-6394a90a91f8 | 2025-12-01 | Warnings | M022 |
| Walgreens Saline | NASAL | WALGREEN COMPANY | 147e45c8-1e71-4c06-89f1-42e9f9683366 | 2025-12-01 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82976-101-00 | 82976010100 | 124 TABLET in 1 POUCH (82976-101-00) | 124 tablet | 2023-05-19 | No | No | Current |