Sore Mouth Cleanser
- Product NDC
- 0363-0085
- 11-digit product format
- 003630085
- Labeler code
- 0363
- Product ID
- 0363-0085_4aa4a2ca-3bc4-815f-e063-6294a90abdfa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrogen Peroxide
- Dosage form
- MOUTHWASH
- Route
- TOPICAL
- Labeler
- Walgreen Co.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-05-02
- Substance
- HYDROGEN PEROXIDE
- Active strength
- 15 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Sore Mouth Cleanser
- 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#
| Identifier | FDA.report destination |
|---|---|
| 358975 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 33223589-4ff4-4e4e-96da-6fa2e4d0f187 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0085-34 | Sore Mouth Cleanser | 236 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 236 | 14 |
DailyMed Dashboard NDC Coverage#
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#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 358975 | hydrogen peroxide 1.5 % Mouthwash | PSN | 33223589-4ff4-4e4e-96da-6fa2e4d0f187 | 14 |
| 358975 | hydrogen peroxide 15 MG/ML Mouthwash | SCD | 33223589-4ff4-4e4e-96da-6fa2e4d0f187 | 14 |
| 358975 | hydrogen peroxide 1.5 % Mouthwash | SY | 33223589-4ff4-4e4e-96da-6fa2e4d0f187 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0085-34 | 00363008534 | 236 mL in 1 BOTTLE, PLASTIC (0363-0085-34) | 236 ml | 2014-05-02 | 0000-00-00 | No | No | Current |