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 | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | b0e5dc67-da7a-42ac-8657-e8e4da6914be | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721ff57-0111-4bbb-e053-2995a90a1a70 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 8129e871-5f31-4138-ae47-f8978fa6287f | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 0301c1bc-db48-4635-97f5-9eaef7ab9579 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | c0c88180-ccdc-4c48-b262-3ec20d4775d4 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | ba011795-6822-4fff-b9c8-5c91cf9972a7 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 462a5f09-131f-4dfa-a502-547c44e4a4a5 | 2025-01-16 | Warnings | M022 |
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | M022 |
| Kanka Triple Action | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | 078fcdab-38a1-4a9a-bdd3-e17446591ea8 | 2025-01-09 | 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 |