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 |
|---|---|---|---|---|---|---|
| Kids Flouride Rinse | SODIUM FLUORIDE | Your Military Exchanges | 5f6f4125-6264-4724-bb7e-a6e100939b41 | 2026-08-28 | Warnings, Adverse reactions | M021 |
| Colgate MaxFresh Clean Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 7cb85fc4-573b-45d7-a430-f2fd17320c43 | 2026-08-26 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 8b210b6c-b712-4f14-906c-306922573a26 | 2026-08-26 | Warnings | M021 |
| COLGATE 2IN1 ICY BLAST | SODIUM FLUORIDE | Colgate-Palmolive Company | 6aad9a91-ba1c-4a27-9269-ea8032feaad0 | 2026-08-26 | Warnings | M021 |
| Crest Pro-Health Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | 59dff762-7f66-8bdc-e063-6294a90a9f18 | 2026-08-25 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Nice-Pak Products, LLC | c71d4064-f938-477b-9346-eb38be65390d | 2026-08-25 | Warnings, Adverse reactions | M021 |
| AIM Whitening with Baking Soda | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0fd0b4-33ba-5764-e054-00144ff88e88 | 2026-08-25 | Warnings | M021 |
| OPTIC WHITE PRO SERIES VIBRANT CLEAN | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | b1ada157-a9a0-4eec-83a2-6e448d7f12dc | 2026-08-21 | Warnings | M021 |
| Therabreath Whitening | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 3ba04b55-38f9-76f3-e063-6394a90a3c03 | 2026-08-21 | Warnings | M021 |
| Therabreath Deep Clean | STANNOUS FLUORIDE | Church & Dwight Co., Inc. | 3c372f26-e0c4-0659-e063-6294a90ae9f9 | 2026-08-21 | Warnings | M021 |
| TheraBreath | POTASSIUM NITRATE, SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 2026-08-21 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Your Military Exchanges | eb95e0ca-a94c-41cb-9f54-6c64ed9a9733 | 2026-08-21 | Warnings, Adverse reactions | M021 |
| Pop On Toothpaste. | POP ON TOOTHPASTE. | POPONSMILES,LLC | 4a0edab5-ae36-91b5-e063-6294a90aa685 | 2026-08-21 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 188dc3ac-64c9-438e-858b-846f725c6ea0 | 2026-08-21 | Warnings | M021 |
| COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT | STANNOUS FLUORIDE | Colgate-Palmolive Company | 178d4535-fa57-4b53-b1f8-5c591f2ea9e7 | 2026-08-21 | Warnings | M021 |
| freshSTART Anticavity fluoride toothpaste. | ANTICAVITY FLUORIDE TOOTHPASTE | Guangzhou Xinuo Technology Co., Ltd. | 596432d5-3541-6dff-e063-6294a90a9d42 | 2026-08-19 | Warnings | M021 |
| Colgate Sensitive ProRelief Whitening | STANNOUS FLUORIDE | Colgate-Palmolive Company | 8d9d485e-6efb-4bca-a779-9e8b0aeed14c | 2026-08-18 | Warnings | M021 |
| SprinJene Natural | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | e64cecc3-0845-4bdf-a449-d78248791ccf | 2026-08-17 | Warnings | M021 |
| ATOMY ANTICAVITY TOOTH | SODIUM MONOFLUOROPHOSPHATE | ATOMY CO., LTD. | 592caccc-e3a9-9c66-e063-6394a90a26e3 | 2026-08-16 | Warnings | M021 |
| SprinJene Health Boost | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 2026-08-14 | 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 |