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 |
|---|---|---|---|---|---|---|
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | ed617c7a-805c-4788-9bce-9b7fead4312d | 2026-03-31 | Warnings | M021 |
| Colgate Total Enamel Strength | STANNOUS FLUORIDE | Colgate-Palmolive Company | 1f29c893-e7c5-4a0e-941b-c2634d821147 | 2026-03-25 | Warnings | M021 |
| AP-24 Whitening | SODIUM MONOFLUOROPHOSPHATE | NSE Products, Inc. | 57e9e68c-41dd-470b-80db-dfaedc0e2a0a | 2026-03-24 | Warnings | M021 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369c0d44-6375-dcae-e063-6394a90a74d0 | 2026-03-24 | Warnings | M021 |
| Euthymol Whitening Purple Corrector | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369bc785-fb77-a56d-e063-6394a90a2e6b | 2026-03-24 | Warnings | M021 |
| SensitiveToothpaste | ANTI SENSITIVETOOTHPASTE | Huain Best Trade Co., Ltd. | 4db239f3-2ad7-3a5b-e063-6294a90a11a7 | 2026-03-23 | Warnings | M021 |
| Crest Bubblegum | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7d6268c7-b273-1bbf-e053-2a91aa0a5d32 | 2026-03-17 | Warnings | M021 |
| Natures Promise Childrens Fluoride Strawberry | SODIUM MONOFLUOROPHOSPHATE | Foodhold U.S.A. | 81a4e196-8b2d-0745-e053-2991aa0a7de6 | 2026-03-16 | Warnings | M021 |
| Stance | 0.63% STANNOUS FLUORIDE CONCENTRATE RINSE | Elevate Oral Care | 3ae8badf-f960-62fd-e054-00144ff8d46c | 2026-03-11 | Warnings | M021 |
| Stance | 0.63% STANNOUS FLUORIDE CONCENTRATE RINSE | Elevate Oral Care | 3ae71258-a8c2-6eb5-e054-00144ff88e88 | 2026-03-11 | Warnings | M021 |
| Delta Travel Kit Comfort plus | SODIUM MONOFLUOROPHOSPHATE | Buzz Products Inc. | d31e0920-4317-1e0c-e053-2a95a90aebeb | 2026-03-11 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | CVS Pharmacy, Inc. | eac346d9-d9c1-4417-8193-390c7a0dcc2a | 2026-03-10 | Warnings, Adverse reactions | M021 |
| Crest Cavity Protection Regular | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6caf3f2e-70a2-4530-99fa-f5af7e4c511a | 2026-03-10 | Warnings | M021 |
| Amerfresh Toothpowder | SODIUM FLUORIDE | Yangzhou ONE & ONLY Personal Care Products Co., LTD | 1cacf93e-aa60-4717-87ab-0568a701a4f3 | 2026-03-10 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | CVS Pharmacy, Inc. | a51357df-6d55-4030-a5db-42da7ba54a37 | 2026-03-09 | Warnings, Adverse reactions | M021 |
| Fluoride | FLUORIDE TOOTHPASTE | McKesson | 4c482e45-0502-a93a-e063-6394a90aa961 | 2026-03-05 | Warnings | M021 |
| Colgate Maximum Cavity Protection Bubble Fruit Flavor | SODIUM FLUORIDE | Colgate-Palmolive Company | 0a1389f6-cac9-3d58-0744-c488abb0bbcc | 2026-03-03 | Warnings | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Amazon.com Services LLC | 349eca80-2e0c-409b-af29-3235fdc0695b | 2026-03-03 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | Amazon.com Services LLC | 03735abc-d1be-4ca0-a497-0a5c5f289402 | 2026-03-03 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | f8036e2e-7541-4922-92b9-0d8319f7b64c | 2026-03-02 | Warnings, Adverse reactions | 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 |