Oral B Mouth Sore
- Product NDC
- 84126-603
- 11-digit product format
- 841260603
- Labeler code
- 84126
- Product ID
- 84126-603_47e526f6-1f0e-c1dd-e063-6394a90a3888
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrogen Peroxide
- Dosage form
- RINSE
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-01-02
- Substance
- HYDROGEN PEROXIDE
- Active strength
- .03 mL/20mL
- 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
- Oral B Mouth Sore
- Brand name suffix
- Special Care Rinse
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROGEN PEROXIDE | .03 mL/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BBX060AN9V | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 22e2dc15-5794-28ed-e063-6394a90a36d3 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84126-603-08 | Oral B Mouth SoreSpecial Care Rinse | 237 mL in 1 BOTTLE, PLASTIC | RINSE | 237 | 7 | |
| 84126-603-16 | Oral B Mouth SoreSpecial Care Rinse | 475 mL in 1 BOTTLE, PLASTIC | RINSE | 475 | 7 |
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 |
|---|---|---|---|---|---|---|
| Murchison Hume Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Buzz Products Inc. | b1a442e1-86cf-cba6-e053-2995a90a593a | 2023-12-20 | Warnings | M021 |
| United Airlines Polaris Kit with Colgate | SODIUM MONOFLUOROPHOSPHATE | Buzz Export Services Pty Ltd (Buzz Products) | de4564a4-1012-baad-e053-2a95a90a11b7 | 2023-12-20 | Warnings | M021 |
| Orajel Complete Protection | SODIUM FLUORIDE | Church & Dwight Co., Inc. | daebd16f-d278-446d-8b7a-33add5a74fdd | 2023-12-19 | Warnings | M021 |
| Orajel Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | Church & Dwight Co., Inc. | 7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb | 2023-12-19 | Warnings | M021 |
| ORTHO GUARD | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd | 2023-12-17 | Warnings | M021 |
| Beyond Activated Coconut Charcoal and Sea Salt | SODIUM FLUORIDE | Beyond International Inc | d075fa15-7309-0c10-e053-2995a90a7c95 | 2023-11-28 | Warnings | M021 |
| Pro-Den Rx | STANNOUS FLUORIDE | Den-mat Holdings, Llc | 9036aa8a-59b1-41b0-b3cb-529d3303a1c0 | 2023-11-20 | Warnings | M021 |
| Fluoridex | STANNOUS FLUORIDE RINSE | DEN-MAT HOLDINGS, LLC | 5e81f073-c0ca-aa38-e053-2a91aa0ab37b | 2023-11-20 | Warnings | M021 |
| Hello Vitamin C Whitening | SODIUM FLUORIDE | Colgate-Palmolive Company | 38a0276e-910c-527d-1736-65928b9d4ca4 | 2023-11-20 | Warnings | M021 |
| POP Feeling Peachy | SODIUM FLUORIDE | LG H&H CO., LTD. | 0abaf99b-9547-46ae-e063-6394a90a6c15 | 2023-11-17 | Warnings | M021 |
| UNIVERSAL ANTI-CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | e3356374-befa-41b0-ab0f-edfd5a062601 | 2023-11-16 | Warnings | M021 |
| ANTI CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 421fc2f0-b118-4e7a-a399-ba4780028c54 | 2023-11-16 | Warnings | M021 |
| UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE | SODIUM FLUORIDE | Universal Distribution Center LLC | 3411924d-1002-460c-83e8-c0c7fbff9ad1 | 2023-11-16 | Warnings | M021 |
| ADVANCED WHITENING ANTI CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e | 2023-11-16 | Warnings | M021 |
| UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 879dfaf0-27c8-41a3-8d01-a1c3eec9edfc | 2023-11-15 | Warnings | M021 |
| EUTHYMOL Extraordinary Pink Whitening | SODIUM FLUORIDE | LG H&H CO., LTD. | 0989936c-237d-dc63-e063-6294a90a885f | 2023-11-07 | Warnings | M021 |
| Eurofresh Whitening | SODIUM FLUORIDE | Farmasi US LLC | b56b2b55-e3a4-785a-e053-2a95a90a7abf | 2023-11-05 | Warnings | M021 |
| Farmasi Whitening | SODIUM FLUORIDE | Farmasi US LLC | 25b3608e-abed-41ca-9971-21981b8a4610 | 2023-11-05 | Warnings | M021 |
| United Airlines Therabody UPP Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | fb6c355b-a67d-c4b4-e053-6394a90a0e66 | 2023-10-26 | Warnings | M021 |
| United Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | 7f348fe7-9918-4934-bed0-f0a77c09d046 | 2023-10-26 | Warnings | M021 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84126-603-08 | 84126060308 | 237 mL in 1 BOTTLE, PLASTIC (84126-603-08) | 237 ml | 2020-01-02 | No | No | Current |
| 84126-603-16 | 84126060316 | 475 mL in 1 BOTTLE, PLASTIC (84126-603-16) | 475 ml | 2020-01-02 | No | No | Current |