FDA.reportPublic FDA data

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 table
IngredientStrength
BENZYL ALCOHOL.1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LKG8494WBHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581456Internal RxNorm lookup
866357Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
42ef8bfa-c4d9-01cf-e063-6394a90ac88aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42829-468-02ZilactinEarly Relief Cold Sore7 g in 1 TUBEGEL71
42829-468-02ZilactinEarly Relief Cold Sore1 in 1 CARTONGEL11

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.

Matched openFDA labels page 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581456benzyl alcohol 10 % Oral GelPSN42ef8bfa-c4d9-01cf-e063-6394a90ac88a1
866357zilactin Early Relief Cold Sore 10 % Oral GelPSN42ef8bfa-c4d9-01cf-e063-6394a90ac88a1
866357benzyl alcohol 0.1 ML/ML Oral Gel [Zilactin Cold Sore]SBD42ef8bfa-c4d9-01cf-e063-6394a90ac88a1
581456benzyl alcohol 0.1 ML/ML Oral GelSCD42ef8bfa-c4d9-01cf-e063-6394a90ac88a1
581456benzyl alcohol 10 % Mucous Membrane Topical GelSY42ef8bfa-c4d9-01cf-e063-6394a90ac88a1
866357Zilactin Cold Sore 0.1 ML/ML Oral GelSY42ef8bfa-c4d9-01cf-e063-6394a90ac88a1
866357Zilactin Cold Sore 10 % Oral GelSY42ef8bfa-c4d9-01cf-e063-6394a90ac88a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42829-468-02428290468021 TUBE in 1 CARTON (42829-468-02) / 7 g in 1 TUBE1 tube2025-11-06NoNoCurrent