PEROXY SHIELD MOUTH SORE
- Product NDC
- 55346-3501
- 11-digit product format
- 553463501
- Labeler code
- 55346
- Product ID
- 55346-3501_42c86f95-5c63-ba41-e063-6294a90af8c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- 1.5% Hydrogen Peroxide
- Dosage form
- RINSE
- Route
- ORAL
- Labeler
- Dental Technologies, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-03
- Substance
- HYDROGEN PEROXIDE
- Active strength
- 1.5 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- PEROXY SHIELD MOUTH SORE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROGEN PEROXIDE | 1.5 mL/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BBX060AN9V | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a72e433b-1b7d-4a0c-e053-2995a90a30c4 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55346-3501-1 | PEROXY SHIELD MOUTH SORE | 1863 mL in 1 BOTTLE, PLASTIC | RINSE | 1863 | 5 | |
| 55346-3501-2 | PEROXY SHIELD MOUTH SORE | 473 mL in 1 BOTTLE | RINSE | 473 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55346-3501 | PEROXY SHIELD MOUTH SORE (1.5% HYDROGEN PEROXIDE) RINSE [DENTAL TECHNOLOGIES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231220_a72e433b-1b7d-4a0c-e053-2995a90a30c4.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 |
|---|---|---|---|---|---|---|
| ORCA Pain Reliever Putty with Menthol | MENTHOL | ORCA Products, LLC | 188cb01a-3d0f-43d9-983e-6475c0c5b06e | 2023-11-10 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 33fbdbc7-e10d-4181-926f-9b591b5b07e3 | 2023-11-08 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0d2c8c0c-4c72-4400-b3b5-ed578fa35167 | 2023-11-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Degasa, S.A. de C.V. | 45ac0275-4c68-3897-e054-00144ff8d46c | 2023-11-05 | Warnings | M022 |
| Oral Pain Relief | BENZOCAINE | GERI-CARE PHARMACEUTICAL CORP | d294a39e-55f4-272d-e053-2995a90ab7f7 | 2023-10-31 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | e10c45e6-d37f-4650-b3e5-07719cc0ea49 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 886d949b-8db1-499c-a277-174f8bc29f34 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | fc8194af-2e77-4ad1-ae75-461dce3ed604 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | baf7d184-07ed-4491-a1fc-9a377b4b0110 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 033034af-c86c-4dbf-90eb-009c117024c6 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 658ada18-2334-4b4e-b08e-702fa127aa14 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | cad932e5-8d7f-4f20-b1c2-febd328152f0 | 2023-10-11 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 2c9519ab-320d-49da-9deb-97a6168fb088 | 2023-10-10 | Warnings | M022 |
| Ioline | BENZOCAINE | Dharma Research, Inc. | b862c974-c024-42c3-986e-b65069437c7b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 651ea978-081d-4c59-b177-6049a69d9415 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | db763237-2910-45b9-be72-da092edc951b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 34316f93-10b4-41cc-8654-625283f0044c | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 142a8824-657e-492a-8e5a-b15eb73383c9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 414cbec9-94e2-4bca-908b-1e79f8db0b27 | 2023-10-10 | Warnings | M022 |
| Sore throat cherry | PHENOL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | de634cf1-ed39-4d8a-8855-006c69b7aee9 | 2023-10-10 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199011 | hydrogen peroxide 1.5 % Oral Solution | PSN | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
| 2480895 | PEROXY SHIELD 1.5 % Oral Solution | PSN | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
| 2480895 | hydrogen peroxide 15 MG/ML Oral Solution [Peroxy Shield] | SBD | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
| 199011 | hydrogen peroxide 15 MG/ML Oral Solution | SCD | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
| 199011 | hydrogen peroxide 1.5 % Oral Solution | SY | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
| 2480895 | Peroxy Shield 1.5 % Oral Solution | SY | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
| 2480895 | Peroxy Shield 15 MG/ML Oral Solution | SY | a72e433b-1b7d-4a0c-e053-2995a90a30c4 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55346-3501-1 | 55346350101 | 1863 mL in 1 BOTTLE, PLASTIC (55346-3501-1) | 1863 ml | 2020-06-12 | 0000-00-00 | No | No | Current |
| 55346-3501-2 | 55346350102 | 473 mL in 1 BOTTLE (55346-3501-2) | 473 ml | 2021-11-24 | 0000-00-00 | No | No | Current |