Zilactin-B
- Product NDC
- 42829-550
- 11-digit product format
- 428290550
- Labeler code
- 42829
- Product ID
- 42829-550_42eec176-84ad-1e81-e063-6394a90afd01
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- benzocaine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- ASCENT CONSUMER PRODUCTS, INC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-06
- Substance
- BENZOCAINE
- Active strength
- .1 g/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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-B
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | .1 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 42eeb3d4-bac6-4e29-e063-6294a90a644d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42829-550-32 | Zilactin-B | 7 g in 1 TUBE | GEL | 7 | 1 | |
| 42829-550-32 | Zilactin-B | 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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 198488 | benzocaine 10 % Oral Gel | PSN | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
| 1542803 | zilactin-B 10 % Oral Gel | PSN | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
| 1542803 | benzocaine 0.1 MG/MG Oral Gel [Zilactin B] | SBD | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
| 198488 | benzocaine 0.1 MG/MG Oral Gel | SCD | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
| 198488 | benzocaine 10 % Oral Gel | SY | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
| 1542803 | Zilactin B 0.1 MG/MG Oral Gel | SY | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
| 1542803 | Zilactin-B 10 % Mucosal Gel | SY | 42eeb3d4-bac6-4e29-e063-6294a90a644d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42829-550-32 | 42829055032 | 1 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE | 1 tube | 2025-11-06 | No | No | Current |