OralLine Kids
- Product NDC
- 55873-003
- 11-digit product format
- 558730003
- Labeler code
- 55873
- Product ID
- 55873-003_1076e667-505a-494a-865a-ee3767e3305e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM FLUORIDE
- Dosage form
- GEL, DENTIFRICE
- Route
- ORAL
- Labeler
- J.M. Murray Center Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-01
- Substance
- SODIUM FLUORIDE
- Active strength
- .15 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55873-003-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55873-003-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55873-003-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55873-003-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55873-003-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55873-003-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55873-003-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55873-003-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 55873-003-01 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 55873-003-01 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 55873-003-01 | 1332a3947898… | d4bfe170f9cd… |
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
- OralLine Kids
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .15 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 416783 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 12c5bee5-e228-4f71-9bfd-c377ee2372a9 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55873-003-01 | 2025-03-18 | C162847 | 48780-1 | f386c64a-3c1a-0266-e053-dadaa90a7c1a | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 |
| 55873-003-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3c1a-0266-e053-dadaa90a7c1a | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55873-003-01 | OralLine Kids | 113.4 g in 1 TUBE | GEL, DENTIFRICE | 113.4 | 6 |
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 |
|---|---|---|---|---|---|---|
| Colgate Total SF Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | 3bba340e-2a62-3b04-41b5-0ed9c13adb13 | 2026-04-22 | Warnings | M021 |
| EverSmile Squirt | SODIUM FLUORIDE 0.05% | Everbrands, Inc. | bc0ef174-2909-469a-b629-0eab4412bdfc | 2026-04-20 | Warnings | M021 |
| Gum Detoxify | STANNOUS FLUORIDE | Walmart | 41d6cc7a-0b87-e474-e063-6294a90ae995 | 2026-04-20 | Warnings | M021 |
| Eversmile Squirt | 2.65% HYDROGEN PEROXIDE | Everbrands, Inc. | 2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf | 2026-04-19 | Warnings | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | H E B | 8d40f693-083c-4eb6-9da1-42675d757e0e | 2026-04-16 | Warnings, Adverse reactions | M021 |
| Eversmile OrthoFoam Anticavity | 0.05% SODIUM FLUORIDE RINSE | Everbrands, Inc. | 9c12e792-94c8-4e29-9a54-e7e70aadade6 | 2026-04-16 | Warnings | M021 |
| Eversmile Squirt | 2.65% HYDROGEN PEROXIDE | Everbrands, Inc. | 6753b426-6d49-4438-a52f-c28e60a0e9d8 | 2026-04-16 | Warnings | M021 |
| Osstem G Gum Health Care Tooth | SODIUM FLUORIDE | Osstem Pharma Co., Ltd | 4f8b4fc0-4c98-5e52-e063-6394a90af710 | 2026-04-15 | Warnings | M021 |
| Crest 3D White Deep Stain Remover Enamel Strength | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | 4f6b8851-c778-8abd-e063-6294a90aef4f | 2026-04-14 | M021 | |
| Crest 3D White Stain Eraser Luxe Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f6beb3b-2521-bfb7-e063-6394a90ad9ea | 2026-04-14 | M021 | |
| Kids Crest Strawberry Rush | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13 | 2026-04-14 | Warnings | M021 |
| Crest Pro-Health Mouthwash Multi-Protection Strong Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f6d11b2-5aa2-ab34-e063-6294a90ac0bc | 2026-04-14 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Publix Super Markets, Inc. | cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb | 2026-04-14 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Publix Super Markets, Inc. | f0e84078-499f-4a5a-bcd2-23f57805de86 | 2026-04-14 | Warnings, Adverse reactions | M021 |
| Crest Pro-Health Advanced Multi-Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 1cfc5b61-c8e5-943d-e063-6394a90a890b | 2026-04-14 | Warnings | M021 |
| Crest Pro-Health Multi-Protection plus Extra Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f6f6299-f95f-2f0e-e063-6294a90a1641 | 2026-04-14 | Warnings | M021 |
| Crest 3D White Strength Whitening Enamel Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f7125aa-3aa2-ca64-e063-6394a90a4cf3 | 2026-04-14 | Warnings | M021 |
| Eversmile TheraFoam | 0.05% SODIUM FLUORIDE RINSE | Everbrands, Inc. | 57da2479-923a-45ec-8149-57b469b11637 | 2026-04-13 | Warnings | M021 |
| Crest Pro-Health Advanced Bacteria Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ce508-fe6e-4045-e063-6294a90ab3e2 | 2026-04-10 | Warnings | M021 |
| Crest Pro-Health Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 4f1d62ae-653e-3046-e063-6294a90abbf8 | 2026-04-10 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 | 6 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 | 6 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 | 6 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 | 6 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 12c5bee5-e228-4f71-9bfd-c377ee2372a9 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55873-003-01 | 55873000301 | 113.4 g in 1 TUBE (55873-003-01) | 113.4 g | 2025-03-01 | 0000-00-00 | No | No | Current |