FDA.reportPublic FDA data

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 table
IngredientStrength
BENZOCAINE.1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198488Internal RxNorm lookup
1542803Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42eeb3d4-bac6-4e29-e063-6294a90a644dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42829-550-32Zilactin-B7 g in 1 TUBEGEL71
42829-550-32Zilactin-B1 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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
application number: M022
Dual-FormulaToothpaste for sensitive teethDUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETHHangzhou Namei Zhikang Technology Co., Ltd.4d735f91-8abc-3a30-e063-6394a90a76392026-03-20WarningsExact identifier
application number: M022
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINENantong Health & Beyond Hygienic Products Inc.a5f0be98-d47e-4307-8044-304a64db774b2026-03-11WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDECVS Pharmacy, Inc.a5dbaadf-76a8-4c48-af2d-f4455e9411f02026-03-09Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDESam's West, Inc78a3e024-73da-40b7-9d9c-099fd6ca9b9e2026-03-03WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
application number: M022
Spring Gene Oil Pulling SensitivityPOTASSIUM NITRATEHealth and Natural Beauty USA Corp294051e3-69ec-4190-8b03-fa34988376b72026-02-26WarningsExact identifier
application number: M022
Lolleez WatermelonPECTINBFY LLC4ba8af8b-5a17-8b8c-e063-6394a90a63f32026-02-25WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198488benzocaine 10 % Oral GelPSN42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803zilactin-B 10 % Oral GelPSN42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803benzocaine 0.1 MG/MG Oral Gel [Zilactin B]SBD42eeb3d4-bac6-4e29-e063-6294a90a644d1
198488benzocaine 0.1 MG/MG Oral GelSCD42eeb3d4-bac6-4e29-e063-6294a90a644d1
198488benzocaine 10 % Oral GelSY42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803Zilactin B 0.1 MG/MG Oral GelSY42eeb3d4-bac6-4e29-e063-6294a90a644d1
1542803Zilactin-B 10 % Mucosal GelSY42eeb3d4-bac6-4e29-e063-6294a90a644d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42829-550-32428290550321 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE1 tube2025-11-06NoNoCurrent