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
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 |
|---|---|---|---|---|---|---|
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 584b38ce-d1ef-4ecc-a887-7c96e7f9669f | 2026-08-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Walgreens | fb93c7f6-e025-4cf2-9997-acfe9a0debdd | 2026-08-19 | Warnings | M022 |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | M022 |
| Ludens Honey Licorice Throat Drops | MENTHOL | Prestige Brands Holdings, Inc. | 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac | 2026-08-19 | Warnings | M022 |
| Ludens Dual Relief | PECTIN AND MENTHOL | Prestige Brands Holdings, Inc. | d0213cb3-ec8e-40cc-82c9-694032f0490f | 2026-08-19 | Warnings | M022 |
| CVS Health Sore Throat Fast Relief Oral Anesthetic | PHENOL | CVS Pharmacy,Inc. | 4fb880db-2185-41ef-a5f9-8983a28d2c5b | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Cherry | PHENOL | CVS Pharmacy,Inc. | 887c68e0-ff44-4bad-b360-56fb99ed9c45 | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Menthol Flavor | PHENOL | CVS PHARMACY,INC. | 665be058-b965-4b78-80b0-dd8524180932 | 2026-08-17 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Harris Teeter, LLC | 7e5f175d-f0d6-4665-ac14-1873d6b99c80 | 2026-08-12 | Warnings | M022 |
| Gingicaine Gel Variety Pak | GINGICAINE GEL VARIETY PAK | Gingi-Pak a Division of the Belport | 62ed4ff3-18f6-5c67-e053-2991aa0a7792 | 2026-08-11 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 5868c5a1-273f-f023-e063-6394a90ac9d8 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58690bb5-9604-26a4-e063-6394a90afdbe | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586918cf-7b13-5999-e063-6294a90a88a9 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586924a0-322d-5dc3-e063-6294a90a1556 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58692e90-de74-52d3-e063-6394a90a9702 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | 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 |