Antigingivitis/Antiplaque
- Product NDC
- 76162-953
- 11-digit product format
- 761620953
- Labeler code
- 76162
- Product ID
- 76162-953_4aba1791-ba47-f1f3-e063-6394a90a55f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetylpyridinium Chloride
- Dosage form
- MOUTHWASH
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-18
- Substance
- CETYLPYRIDINIUM CHLORIDE
- Active strength
- .5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings for this product
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse reaction DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1123 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Scan here for more information or call 1-888-423-0139 DSP-TN-21091 DSP-MO-20087
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antigingivitis/Antiplaque
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETYLPYRIDINIUM CHLORIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D9OM4SK49P |
| Rxcui | 1251617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76162-953-86 | Antigingivitis/Antiplaque | 1000 mL in 1 BOTTLE, PLASTIC | MOUTHWASH | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76162-953 | ANTIGINGIVITIS/ANTIPLAQUE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC] | 2 | Current NDC, 1 package rows | 20250425_3fefe9b3-d61d-494d-bd85-5d2cf8321398.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-953-86 | 76162095386 | 1000 mL in 1 BOTTLE, PLASTIC (76162-953-86) | 1000 ml | 2024-04-18 | No | No | Current |