Perox-A-Mint Solution
- Product NDC
- 53462-075
- 11-digit product format
- 534620075
- Labeler code
- 53462
- Product ID
- 53462-075_550655a0-abc2-dae6-e063-6294a90a995f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- HYDROGEN PEROXIDE
- Dosage form
- MOUTHWASH
- Route
- BUCCAL
- Labeler
- Sage Products, LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-05-21
- 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 | 53462-075 | 53462-075-40 | 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
- Perox-A-Mint Solution
- 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 |
|---|---|
| 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 53462-075-30 | 2022-02-22 | Perox-A-Mint® Solution |
| 53462-075-30 | 2022-02-22 | Perox-A-Mint® Solution |
| 53462-075-40 | 2022-02-22 | Perox-A-Mint® Solution |
| 53462-075-40 | 2022-02-22 | Perox-A-Mint® Solution |
| 53462-075-60 | 2022-02-22 | Perox-A-Mint® Solution |
| 53462-075-60 | 2022-02-22 | Perox-A-Mint® Solution |
| 53462-075-30 | 2022-01-28 | Perox-A-Mint® Solution |
| 53462-075-30 | 2022-01-28 | Perox-A-Mint® Solution |
| 53462-075-40 | 2022-01-28 | Perox-A-Mint® Solution |
| 53462-075-40 | 2022-01-28 | Perox-A-Mint® Solution |
| 53462-075-60 | 2022-01-28 | Perox-A-Mint® Solution |
| 53462-075-60 | 2022-01-28 | Perox-A-Mint® Solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53462-075-30 | Perox-A-Mint Solution | 44 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 44 | 14 | |
| 53462-075-40 | Perox-A-Mint Solution | 237 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 237 | 14 | |
| 53462-075-60 | Perox-A-Mint Solution | 7 mL in 1 PACKET | MOUTHWASH | 7 | 14 | |
| 53462-075-60 | QCare Oral Cleansing and Suctioning System, Q8 | 7 mL in 1 PACKET | MOUTHWASH | 7 mL | 15 mg in 1mL | 11 |
| 53462-075-30 | Short Term Oral Swab System | 44 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 44 mL | 15 mg in 1mL | 7 |
| 53462-075-60 | QCare Oral Cleansing and Suctioning System, Q4 | 7 mL in 1 PACKET | MOUTHWASH | 28 mL | 15 mg in 1mL | 7 |
| 53462-075-60 | Suction Toothbrush with Perox-A-Mint Solution | 7 mL in 1 PACKET | MOUTHWASH | 7 mL | 15 mg in 1mL | 6 |
| 53462-075-30 | Short Term Oral Care System | 44 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 44 mL | 15 mg in 1mL | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53462-075-30 | ML - Milliliter | 53462-075 | beb020b4-a3b3-402a-afb9-4fd8e44bcf6f | 1 | 2013-11-04 |
| 53462-075-40 | ML - Milliliter | 53462-075 | dfa841fb-924e-4efb-bc49-688eeb1c471c | 1 | 2013-11-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53462-075 | PEROX-A-MINT SOLUTION (HYDROGEN PEROXIDE) MOUTHWASH [SAGE PRODUCTS, LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20241127_50823ff5-ad08-4449-bc4a-9a8ae25ec0d5.zip |
| 53462-075 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC] | 11 | Current NDC, Legacy NDC | 20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip |
| 53462-075 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 7 | Current NDC, Legacy NDC | 20180629_567bf599-4958-91c7-5c01-9c38a0d2da52.zip |
| 53462-075 | SHORT TERM ORAL SWAB SYSTEM (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC] | 7 | Current NDC, Legacy NDC | 20190118_e72f118a-c534-4f37-a104-9c748c154724.zip |
| 53462-075 | SUCTION TOOTHBRUSH WITH PEROX-A-MINT SOLUTION (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 6 | Current NDC, Legacy NDC | 20190920_014175de-0f9f-47f0-a04e-02d66ada1cdd.zip |
| 53462-075 | SHORT TERM ORAL CARE SYSTEM (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC] | 3 | Current NDC, Legacy NDC | 20190118_b6e3e97d-3f9a-4787-82d7-e992ade05974.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 |
|---|---|---|---|---|---|---|
| SENSODYNE Rapid Relief | STANNOUS FLUORIDE | Haleon US Holdings LLC | f9589e7c-c5ca-4465-8d37-47ad6c69249f | 2024-03-06 | Warnings | M022 |
| SENSODYNE Repair and Protect Extra Fresh | STANNOUS FLUORIDE | Haleon US Holdings LLC | 34260c69-d829-46c0-b12a-5136ee073ba1 | 2024-03-06 | Warnings | M022 |
| AQUAFRESH SENSITIVE MAXIMUM STRENGTH | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 76adbccb-0812-4407-a6fc-a57e6f144fbb | 2024-03-05 | Warnings | M022 |
| SENSODYNE Advanced Whitening | POTASSIUM NITRATE | Haleon US Holdings LLC | a06e2549-3c4e-4818-b53e-1dea6828219f | 2024-03-04 | Warnings | M022 |
| Sensodyne Extra Whitening Cool Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | c977f2c4-e0f3-44d2-aa7a-845f0583af3e | 2024-03-04 | Warnings | M022 |
| Sensodyne Natural white | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 911ac7e4-2b92-43d5-af0b-b5f741b088fb | 2024-03-04 | Warnings | M022 |
| Sensodyne Nourish Healthy White | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | aca38560-2fd7-47be-9e93-2abc3214e856 | 2024-03-04 | Warnings | M022 |
| Sensodyne Nourish Gently Soothing | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 5403ab67-532c-4bdf-9b06-07b1866f37f1 | 2024-03-04 | Warnings | M022 |
| SENSODYNE PRONAMEL Active Shield Fresh Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | e8684615-f544-4871-b935-0a0f93639d7d | 2024-03-04 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Fresh Mint | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd | 2024-03-04 | Warnings | M022 |
| Made by Dentists Sensitive and Whitening Fresh Mint | POTASSIUM NITRATE, SODIUM FLUORIDE | MADE BY DENTISTS INC | 0d379c26-69ff-4666-9ad5-7618f0bd139f | 2024-02-27 | Warnings | M022 |
| Polident ProPartial | STANNOUS FLUORIDE | Haleon US Holdings LLC | 557eeb32-64f4-41e8-ada4-91bd39ae2920 | 2024-02-07 | Warnings | M022 |
| SENSODYNE PRONAMEL Daily Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 2024-01-24 | Warnings | M022 |
| Peppermint Twist | FLUORIDE | Caldwell Health LLC | 4b28cdd1-0dba-42f5-a9e8-06d9e75b2396 | 2024-01-17 | Warnings | M022 |
| The Natural Dentist Groovy Grape | FLUORIDE | Caldwell Consumer Health LLC | 087abbed-1f58-4b45-a76b-a950fa81c18c | 2024-01-16 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | Pharma Nobis, LLC | e42fccc2-1b4f-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M022 |
| Sunmark Benzoin Compound Tincture | BENZOIN RESIN | Strategic Sourcing Services LLC | 0c96d810-83dc-47d3-9a75-63a79feaad0a | 2023-12-19 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | b33b5896-673b-498c-8a58-76ece8552f7a | 2023-12-15 | Warnings | M022 |
| Povidone Iodine | POVIDONE IODINE ORAL RINSE 0.5% | Humco Holding Group, Inc. | b83dbdd1-ff63-caf8-e053-2a95a90a5764 | 2023-12-15 | Warnings | M022 |
| Moon Whitening Gel Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c556a29-a697-3a66-e063-6394a90abfee | 2023-12-12 | Warnings | M022 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53462-075-30 | 53462007530 | 44 mL in 1 BOTTLE, PLASTIC (53462-075-30) | 44 ml | 1998-05-21 | 0000-00-00 | No | No | Current |
| 53462-075-40 | 53462007540 | 237 mL in 1 BOTTLE, PLASTIC (53462-075-40) | 237 ml | 1998-05-21 | 0000-00-00 | No | No | Current |
| 53462-075-60 | 53462007560 | 7 mL in 1 PACKET (53462-075-60) | 7 ml | 1998-05-21 | 0000-00-00 | No | No | Current |