Ionite H
- Product NDC
- 53045-271
- 11-digit product format
- 530450271
- Labeler code
- 53045
- Product ID
- 53045-271_91060eb1-2d2e-4100-912f-05e7b46c9ae3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Dharma Research, Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-08-02
- Substance
- STANNOUS FLUORIDE
- Active strength
- .4 mg/100g
- 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
- Ionite H
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | .4 mg/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 237847 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 042636cf-8b61-4022-b0a1-af09c06b145b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53045-271-04 | Ionite H | 122 g in 1 TUBE | GEL, DENTIFRICE | 122 | 2 |
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 |
|---|---|---|---|---|---|---|
| Crest Complete plus Whitening plus Scope Outlast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 960e0e3e-10e8-7426-e053-2a95a90a5b02 | 2026-02-12 | Warnings | M021 |
| Crest Fresh and White | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e | 2026-02-12 | Warnings | M021 |
| Kids Crest Cavity Protection Sparkle Fun | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 126c6f39-0ef7-40ee-b3ba-e56a76739c57 | 2026-02-12 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | CVS Pharmacy, Inc. | b2f7490c-e2af-49df-b054-70fb4815f729 | 2026-02-11 | Warnings, Adverse reactions | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | FORMIA LIMITED | b7d7c41e-f8b6-4e55-8acd-78eb6dda47c5 | 2026-02-09 | Warnings | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | FORMIA LIMITED | 48ef2635-7157-4cd7-9f99-967f0143f7f1 | 2026-02-09 | Warnings | M021 |
| Made by Dentists For Kids Eyeball Juice (Watermelon) | SODIUM FLUORIDE | MADE BY DENTISTS INC | 287887df-64de-4b5d-80e2-146c77c0fa8b | 2026-02-09 | Warnings | M021 |
| PERIOSCIENCES White Care AO Pro | SODIUM FLUORIDE | PERIOSCIENCES LLC | 092bdfa3-6267-439e-9320-e51b4805d1a1 | 2026-02-09 | Warnings | M021 |
| PERIOSCIENCES HYDRATING AO Pro | SODIUM MONOFLUOROPHOSPHATE | PERIOSCIENCES LLC | 5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3 | 2026-02-09 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Retail Business Services, LLC | 77c066cf-f064-45d3-9732-4433165ba9ef | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Retail Business Services, LLC | d1c878a9-2151-4986-be09-cbab658cdd31 | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Retail Business Services, LLC | 542e067a-c134-44c9-b962-f2a2b667b76f | 2026-02-06 | Warnings, Adverse reactions | M021 |
| Colgate 5g Toothbrush Kit | SODIUM MONOFLUOROPHOSPHATE | Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd. | 4f0fda5e-ef42-42c3-8270-3ba614650ad1 | 2026-02-06 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Retail Business Services, LLC | 3954edfd-f7f1-4218-9ee2-23f5b3661b4e | 2026-02-06 | Warnings, Adverse reactions | M021 |
| TheraBreath Kids Anticavity Oral Rinse Bubblegum | ANTICAVITY ORAL RINSE | Church & Dwight Co., Inc. | 2770424d-7416-66d4-e063-6394a90ad4b1 | 2026-02-06 | Warnings | M021 |
| Crest Pro-Health Sensitivity Whitening Plus Scope | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 463b7820-a5ce-f8b5-e063-6394a90aa018 | 2026-02-05 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Publix Super Markets, Inc. | 14494238-872b-49e2-8bf7-df3844a0a6c8 | 2026-02-05 | Warnings, Adverse reactions | M021 |
| HAPEE EXPLOSIVE MENTHOL RED 150 | SODIUM MONOFLUOROPHOSPHATE | LAMOIYAN CORPORATION | 14c14694-6149-40a8-aff2-660d39f7e0c1 | 2026-02-05 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | HARRIS TEETER | f759e9e4-6de2-4b80-903b-e67c06e36295 | 2026-02-04 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | HARRIS TEETER | 571f7628-fd59-462f-96dd-67aeaa98cff1 | 2026-02-04 | Warnings, Adverse reactions | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 237847 | stannous fluoride 0.4 % Oral Gel | PSN | 042636cf-8b61-4022-b0a1-af09c06b145b | 2 |
| 237847 | stannous fluoride 0.004 MG/MG Oral Gel | SCD | 042636cf-8b61-4022-b0a1-af09c06b145b | 2 |
| 237847 | stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel | SY | 042636cf-8b61-4022-b0a1-af09c06b145b | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53045-271-04 | 53045027104 | 122 g in 1 TUBE (53045-271-04) | 122 g | 2015-08-02 | 0000-00-00 | No | No | Current |