Plak Smacker
- Product NDC
- 55346-0418
- 11-digit product format
- 553460418
- Labeler code
- 55346
- Product ID
- 55346-0418_210c6251-660e-5b6a-e054-00144ff88e88
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- GEL
- Route
- DENTAL; ORAL
- Labeler
- Dental Technologies, Inc.
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2007-12-31
- Marketing end
- 0000-00-00
- Substance
- STANNOUS FLUORIDE
- Active strength
- 1 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55346-0418-2 | 2025-11-04 | C162847 | 48780-1 | 9d75b9d0-ac84-f424-e053-dadaa90a57ce | Drug Facts |
| 55346-0418-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ac84-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| STANNOUS FLUORIDE | ACTIVE INGREDIENT | 3FTR44B32Q | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55346-0418 | PLAK SMACKER (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.] | 4 | Legacy NDC | 20151124_3b21d029-271b-43f4-9406-429507621bf7.zip |