Esunix Oral Bacteriostatic Gel
- Product NDC
- 87118-006
- 11-digit product format
- 871180006
- Labeler code
- 87118
- Product ID
- 87118-006_45bc8e85-cabf-40fc-e063-6294a90a4427
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetylpyridinium Chloride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Xiling (Zhenjiang) Medical Technology Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-21
- Substance
- CETYLPYRIDINIUM CHLORIDE
- Active strength
- .06 g/100g
- 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
- Esunix Oral Bacteriostatic Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETYLPYRIDINIUM CHLORIDE | .06 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| D9OM4SK49P | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2723721 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87118-006-01 | Esunix Oral Bacteriostatic Gel | 1 g in 1 TUBE | GEL, DENTIFRICE | 1 | 3 | |
| 87118-006-02 | Esunix Oral Bacteriostatic Gel | 10 in 1 BOX | GEL, DENTIFRICE | 10 | 3 |
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 |
|---|---|---|---|---|---|---|
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2723721 | cetylpyridinium chloride 0.06 % Oral Gel | PSN | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 3 |
| 2723721 | cetylpyridinium chloride 0.0006 MG/MG Oral Gel | SCD | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 3 |
| 2723721 | cetylpyridinium chloride 0.06 % Oral Gel | SY | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87118-006-01 | 87118000601 | 1 g in 1 TUBE | 1 g | Historical | |||
| 87118-006-02 | 87118000602 | 10 TUBE in 1 BOX (87118-006-02) / 1 g in 1 TUBE (87118-006-01) | 10 tube | 2025-09-21 | No | No | Current |