TeethWhitening Kit
- Product NDC
- 83778-012
- 11-digit product format
- 837780012
- Labeler code
- 83778
- Product ID
- 83778-012_29ae5783-e7c6-a892-e063-6394a90a47e2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TeethWhitening Kit
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Jiangxi Dentalbright Technology Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-14
- Substance
- POTASSIUM CITRATE; PHTHALIMIDOPEROXYCAPROIC ACID; TRIBASIC CALCIUM PHOSPHATE
- Active strength
- 3; 12; 1 g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
- 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
- TeethWhitening Kit
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM CITRATE | 3 g/100mL |
| PHTHALIMIDOPEROXYCAPROIC ACID | 12 g/100mL |
| TRIBASIC CALCIUM PHOSPHATE | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| EE90ONI6FF | Internal UNII lookup |
| 5OEJ6FAL6C | Internal UNII lookup |
| 91D9GV0Z28 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 29393313-217a-dc3a-e063-6294a90addb1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83778-012-01 | TeethWhitening Kit | 6 mL in 1 BOTTLE | CREAM | 6 | 2 |
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 |
|---|---|---|---|---|---|---|
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83778-012-01 | 83778001201 | 6 mL in 1 BOTTLE (83778-012-01) | 6 ml | 2024-12-14 | No | No | Current |