FDA.reportPublic FDA data

S.T.37

Product NDC
69846-860
Requested package NDC
69846-860-01
11-digit product format
698460860
Labeler code
69846
Product ID
69846-860_e9b8b62e-5c71-4698-9989-bbc2e4d589b4
Type
HUMAN OTC DRUG
Nonproprietary name
Hexylresorcinol
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
NUMARK BRANDS, INC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1929-11-20
Substance
HEXYLRESORCINOL
Active strength
1.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
S.T.37
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEXYLRESORCINOL1.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R9QTB5E82NInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d7acca2-aa8a-5272-e813-faab039cc798Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69846-860-00S.T.37236.5 mL in 1 BOTTLESOLUTION236.55
69846-860-00S.T.371 in 1 AMPULESOLUTION15
69846-860-01S.T.37473 mL in 1 BOTTLESOLUTION4735
69846-860-01S.T.371 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69846-860S.T.37 (HEXYLRESORCINOL) SOLUTION [NUMARK BRANDS, INC]4Current NDC, Legacy NDC, 4 package rows20241222_7d7acca2-aa8a-5272-e813-faab039cc798.zip

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 23 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc9315bd7c-44db-42c8-a9df-aaaa66153c172025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc56185c5f-6f6c-4976-bf18-540b076d90a62025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc88cadb9e-17ab-44bb-b4fe-fcfd6b7334652025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf71b0ab5-0605-4807-b835-903e19aaf2a82025-01-09WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69846-860-01698460860011 BOTTLE in 1 CARTON (69846-860-01) / 473 mL in 1 BOTTLE1 bottle1929-11-200000-00-00NoNoCurrent