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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
application number: M022
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
application number: M022
WinCo Foods Maximum Strength Oral AnalgesicBENZOCAINEWinCo Foods, LLCc22a7726-8c3f-41bf-b852-8456b2be6f932025-10-28WarningsExact identifier
application number: M022
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
application number: M022
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
application number: M022
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and CoughMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.6b1a50d0-be54-4fcb-b5e2-b47abf3555c02025-10-23WarningsExact identifier
application number: M022
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
application number: M022
Boka SensitivePOTASSIUM NITRATEKaraka LLC40be9fab-53db-c67a-e063-6394a90a48cb2025-10-23WarningsExact identifier
application number: M022
Canker Care PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.1ec960db-52d5-4d99-a7f7-a2e538d287242025-10-20WarningsExact identifier
application number: M022
meijer Sensitive EXTRA WHITENINGPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bbcffb88-0bd4-4883-bb83-0b7a1428ad122025-10-20WarningsExact identifier
application number: M022
Quality Choice Maximum Strength Oral Pain RelievingBENZOCAINEChain Drug Marketing Association Incdbde8e7f-85d8-4083-b01a-3a7e410a77472025-10-17WarningsExact identifier
application number: M022
Quality ChoiceBENZOCAINEChain Drug Marketing Association, Inc.24c3c4a3-bd76-198d-e063-6394a90ad45a2025-10-16WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact identifier
application number: M022
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCe8a62f24-1db6-45fb-b6e1-5e57103f82bc2025-10-14WarningsExact identifier
application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINTPOTASSIUM NITRATE, SODIUM FLUORIDEAshtel Studios, Inc.bc74d2a6-fe34-44cf-b015-70ed4d47c9332025-10-13WarningsExact 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