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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |