FDA.reportPublic FDA data

Sunmark Benzoin Compound Tincture

Product NDC
49348-138
11-digit product format
493480138
Labeler code
49348
Product ID
49348-138_0ce57521-f389-2c51-e063-6394a90a3b10
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoin Resin
Dosage form
LIQUID
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
BENZOIN RESIN
Active strength
1000 mg/mL
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
Sunmark Benzoin Compound Tincture
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOIN RESIN1000 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GK21SBA74RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c96d810-83dc-47d3-9a75-63a79feaad0aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-138-30Sunmark Benzoin Compound Tincture59 mL in 1 BOTTLE, PLASTICLIQUID597

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-138-30ML - Milliliter49348-13821292d4c-2018-4c88-aa5e-4e688e77f5b012021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOIN RESINACTIVE INGREDIENTGK21SBA74RSUNMARK BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [MCKESSON]1
BENZOIN RESINACTIVE MOIETYGK21SBA74RSUNMARK BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [MCKESSON]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSUNMARK BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [MCKESSON]1
ALOEINACTIVE INGREDIENTV5VD430YW9SUNMARK BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [MCKESSON]1
TOLU BALSAMINACTIVE INGREDIENTTD2LE91MBESUNMARK BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-138SUNMARK BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [STRATEGIC SOURCING SERVICES LLC]7Current NDC, Legacy NDC, 1 package rows20231220_0c96d810-83dc-47d3-9a75-63a79feaad0a.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 8 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDEMeijer, Inc.c9c17224-9304-403a-b6a1-9c8bd94e3d942026-02-19Warnings, Adverse reactionsExact identifier
application number: M022
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
application number: m022
Sore Mouth CleanserHYDROGEN PEROXIDEWalgreen Co.33223589-4ff4-4e4e-96da-6fa2e4d0f1872026-02-12Warnings, Adverse reactionsExact identifier
application number: M022
PERIOSCIENCES SENSITIVE AO ProPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLCacca8964-b575-468c-8b40-514dfbf507782026-02-09WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)e19228e9-6f87-456e-a222-f979a234d5892026-02-06WarningsExact identifier
application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
application number: M022
Sootheez Strawberry LemonadePECTINPrimrose Candy Co.49e2b303-1018-cd13-e063-6394a90ae3002026-02-02WarningsExact identifier
application number: M022
Sootheez Berry LemonadePECTINPrimrose Candy Co.49cee56f-c45f-6c79-e063-6294a90a5f8f2026-02-01WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDERite Aid Corporation294418aa-640d-42be-ad07-de31da7a7ccc2026-01-30Warnings, Adverse reactionsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
application number: M022
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
application number: M022
Crest Pro-Health All Day Clean BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company48eaca4c-19c2-2dd2-e063-6394a90a3e082026-01-21WarningsExact identifier
application number: M022
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINEUniversal Distribution Center LLCe276ba37-46fb-4ed9-9ee1-c08a2a89704a2026-01-20WarningsExact identifier
application number: M022
Equate Orasol20% BENZOCAINEWAL-MART STORES INC.08404780-8252-4484-b1c3-8970803f74f82026-01-19WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-138-304934801383059 mL in 1 BOTTLE, PLASTIC (49348-138-30) 59 ml2017-12-120000-00-00NoNoCurrent