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 22 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWinCo Foods, LLC9417b340-942b-48bf-bbfd-4cd5154082b92025-02-12WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCb291811f-8fac-45e2-a9a2-b3ecc0813d0d2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCfea30599-5e3b-4163-9660-d41b3fcee1432025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC3be68966-199c-481e-8b9e-e994c41fd96a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCccdee0cc-2bc9-4165-a411-02f4f900d86a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b72025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC69c4dd1b-a0db-4495-bfc3-faffdfdf59bf2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCd5ef3e65-35e8-4323-9f33-3076b561e1052025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC746df21c-e92e-4a71-b1c6-baf99785a43e2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC2345e614-c7b6-448c-8e07-31700bade91c2025-01-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Belport Company, Inc. DBA Gingi-Pak142062ca-6f8f-78d2-e063-6294a90a19d82025-01-29Warnings, Adverse reactionsExact identifier
application number: M022
CHLORASEPTIC MAXMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.edd12a2d-aa27-4f15-9ce6-862e4b6144c42025-01-23WarningsExact identifier
application number: M022
meijer Sensitive FRESH MINTPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bea36d55-1a5d-40c0-b422-92fb36043ee62025-01-23WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC159d412c-6d1a-45d4-88c0-8c93960f946e2025-01-21WarningsExact identifier
application number: M022
SEACALL MouthwashMOUTHWASHGuangdong Quadrant Ecological Technology Co., Ltd.2c1a7eed-6a7c-eeb2-e063-6394a90aafcc2025-01-19WarningsExact identifier
application number: M022
BENZOCAINE RaspberryBENZOCAINEDarby Dental Supply, LLCdd805400-26c5-4c18-ade2-821298233f9b2025-01-17WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCc68fd8c7-7ec3-cc3f-e053-2995a90a43952025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.d22f7776-1b3c-4744-bcfe-8d9597218d732025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9c6a26e8-1253-49f7-9ce2-45c0d39f05c52025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.48178733-7433-41ec-b178-1314e0edab1a2025-01-16WarningsExact 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