Peroxyl Mouth Sore Mild Mint
- Product NDC
- 0126-0083
- 11-digit product format
- 001260083
- Labeler code
- 0126
- Product ID
- 0126-0083_0df671b6-d668-41ee-935d-838a62924b58
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrogen Peroxide
- Dosage form
- RINSE
- Route
- BUCCAL
- Labeler
- Colgate Oral Pharmaceuticals Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-01-01
- Substance
- HYDROGEN PEROXIDE
- Active strength
- 15 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0126-0083 | 0126-0083-31 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
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
- Peroxyl Mouth Sore Mild Mint
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROGEN PEROXIDE | 15 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BBX060AN9V | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b1e1b7c9-dea7-4d64-b6a8-5343f4176359 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0126-0083-16 | Peroxyl Mouth Sore Mild Mint | 500 mL in 1 BOTTLE, PLASTIC | RINSE | 500 | 18 | |
| 0126-0083-22 | Peroxyl Mouth Sore Mild Mint | 1000 mL in 1 BOTTLE | RINSE | 1000 | 18 | |
| 0126-0083-31 | Peroxyl Mouth Sore Mild Mint | 946 mL in 1 BOTTLE | RINSE | 946 | 18 | |
| 0126-0083-70 | Peroxyl Mouth Sore Mild Mint | 10 mL in 1 POUCH | RINSE | 10 | 18 | |
| 0126-0083-70 | Peroxyl Mouth Sore Mild Mint | 50 in 1 CARTON | RINSE | 50 | 18 | |
| 0126-0083-99 | Peroxyl Mouth Sore Mild Mint | 250 mL in 1 BOTTLE, PLASTIC | RINSE | 250 | 18 | |
| 0126-0083-70 | PEROXYL MOUTH SORE MILD MINT | 50 in 1 CARTON | RINSE | 50 | 1 | |
| 0126-0083-70 | PEROXYL MOUTH SORE MILD MINT | 10 mL in 1 POUCH | RINSE | 10 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0126-0083 | PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS INC.] | 18 | Current NDC, Legacy NDC, 6 package rows | 20241127_b1e1b7c9-dea7-4d64-b6a8-5343f4176359.zip |
| 0126-0083 | PEROXYL MOUTH SORE MILD MINT (HYDROGEN PEROXIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20151218_818575ec-5136-4d4f-a0d4-51a7770499be.zip |
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 |
|---|---|---|---|---|---|---|
| Oral Gel Oral Pain Relief | BENZOCAINE BENZALKONIUM CHLORIDE | Savvy Care and Cosmetics | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2024-12-19 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint | SODIUM BICARBONATE | Lotus Brands, Inc. | 4a95c8c1-db7c-4791-ac58-3eac216a0126 | 2024-12-18 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon | SODIUM BICARBONATE | Lotus Brands, Inc. | 6703b29d-cdc9-4c74-91c0-fb0c98dd043e | 2024-12-18 | Warnings | M022 |
| Red Cross Oral Pain Relief | BENZOCAINE | The Mentholatum Company | cbd41429-f730-4577-9f06-ef1831cf62e1 | 2024-12-17 | Warnings | M022 |
| Red Cross Canker Sore | BENZOCAINE | The Mentholatum Company | 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 | 2024-12-17 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | 116956644 | 2981217f-f250-c090-e063-6294a90a85b0 | 2024-12-17 | Warnings | M022 |
| Kank-A Mouth Pain | BENZOCAINE | Blistex Inc. | eebc03ba-f849-4e70-a653-834f383b6aa4 | 2024-12-17 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8282a4a6-b77c-75fc-e053-2991aa0ad4ac | 2024-12-16 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | 9452bff4-8c08-eff9-e053-2a95a90a67ed | 2024-12-16 | Warnings | M022 |
| PHENOL | PHENOL | CHAIN DRUG MARKETING ASSOCIATION INC. | 2379e23a-72fe-4e94-9d7e-9b623c0db174 | 2024-12-13 | Warnings | M022 |
| KANKA SoftBrush | BENZOCAINE AND ZINC CHLORIDE | Blistex Inc | 093f3545-1d8e-48a3-a533-e9c3ae6d740b | 2024-12-12 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 826eaef8-4457-3dc2-e053-2991aa0a528b | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8281700c-10f9-841c-e053-2991aa0a918f | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | e3da0e63-a891-72bd-e053-2a95a90a58bc | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories, Inc. | e3d924b5-0788-46d3-e053-2995a90a027b | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | fa433031-7376-0e5b-e053-6394a90a5f75 | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | eedf13dc-a009-027a-e053-2995a90a8ec8 | 2024-12-11 | Warnings | M022 |
| NATURAL LEMON MINT HERB THROAT DROPS | MENTHOL | Ricola USA Inc. | 763e8234-60be-4b1f-9f78-01c574f35d0a | 2024-12-10 | Warnings | M022 |
| Natural Cherry Honey Herb Throat Drops | MENTHOL | Ricola USA Inc. | 989f8509-cd28-48e7-9aa1-baddfbcac95a | 2024-12-10 | Warnings | M022 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0126-0083-16 | 00126008316 | 500 mL in 1 BOTTLE, PLASTIC (0126-0083-16) | 500 ml | 2009-01-01 | 0000-00-00 | No | No | Current |
| 0126-0083-22 | 00126008322 | 1000 mL in 1 BOTTLE (0126-0083-22) | 1000 ml | 2020-08-31 | 0000-00-00 | No | No | Current |
| 0126-0083-31 | 00126008331 | 946 mL in 1 BOTTLE (0126-0083-31) | 946 ml | 2020-08-29 | 0000-00-00 | No | No | Current |
| 0126-0083-70 | 00126008370 | 50 POUCH in 1 CARTON (0126-0083-70) / 10 mL in 1 POUCH | 50 pouch | 2017-03-15 | 0000-00-00 | No | No | Current |
| 0126-0083-99 | 00126008399 | 250 mL in 1 BOTTLE, PLASTIC (0126-0083-99) | 250 ml | 2015-01-01 | 0000-00-00 | No | No | Current |