Zilactin
- Product NDC
- 42829-468
- 11-digit product format
- 428290468
- Labeler code
- 42829
- Product ID
- 42829-468_42ef8c05-236d-12e9-e063-6394a90ae7d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- benzyl alcohol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- ASCENT CONSUMER PRODUCTS, INC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-06
- Substance
- BENZYL ALCOHOL
- Active strength
- .1 g/g
- Pharmacologic classes
- Pediculicide [EPC]
- 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
- Zilactin
- Brand name suffix
- Early Relief Cold Sore
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZYL ALCOHOL | .1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LKG8494WBH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42829-468-02 | ZilactinEarly Relief Cold Sore | 7 g in 1 TUBE | GEL | 7 | 1 | |
| 42829-468-02 | ZilactinEarly Relief Cold Sore | 1 in 1 CARTON | GEL | 1 | 1 |
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 |
|---|---|---|---|---|
| 581456 | benzyl alcohol 10 % Oral Gel | PSN | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
| 866357 | zilactin Early Relief Cold Sore 10 % Oral Gel | PSN | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
| 866357 | benzyl alcohol 0.1 ML/ML Oral Gel [Zilactin Cold Sore] | SBD | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
| 581456 | benzyl alcohol 0.1 ML/ML Oral Gel | SCD | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
| 581456 | benzyl alcohol 10 % Mucous Membrane Topical Gel | SY | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
| 866357 | Zilactin Cold Sore 0.1 ML/ML Oral Gel | SY | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
| 866357 | Zilactin Cold Sore 10 % Oral Gel | SY | 42ef8bfa-c4d9-01cf-e063-6394a90ac88a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42829-468-02 | 42829046802 | 1 TUBE in 1 CARTON (42829-468-02) / 7 g in 1 TUBE | 1 tube | 2025-11-06 | No | No | Current |