FDA.reportPublic FDA data

Benzoin Tincture

Product NDC
70677-1200
11-digit product format
706771200
Labeler code
70677
Product ID
70677-1200_29814e8e-aeff-1f54-e063-6294a90ab7f9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoin Resin
Dosage form
LIQUID
Route
TOPICAL
Labeler
116956644
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-17
Substance
BENZOIN RESIN
Active strength
1000 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
Benzoin Tincture
Listing expiration
2027-12-31

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
2981217f-f250-c090-e063-6294a90a85b0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1200-1Benzoin Tincture59 mL in 1 BOTTLE, GLASSLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1200BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [116956644]1Current NDC, 1 package rows20241220_2981217f-f250-c090-e063-6294a90a85b0.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 26 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.69271b7a-18c0-4445-8164-cb1620fb54752025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.40bd7406-7ee6-47fe-8481-0a4c8cefce652025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.43194fe1-87a1-4ffa-ad73-a1dcec91fd632025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.b0b3ab27-704a-44b8-8473-d21ac3359ba12025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.39f64f10-f442-45a9-a060-9f99e78c678d2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.ed5a294a-fc03-43dd-825d-23a2320609002025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.be558e5b-cf35-4035-a69c-8d66deeac6b22025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.a2591a96-ed66-45b1-abf6-6b26d0bb4f442025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.efe92e48-5086-4b61-a298-0d8ceefe100e2025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.1d6a1182-ab63-460a-ab91-8d4c2ae5d01e2025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e1db79a4-4a24-4c3f-9ee9-2af3f876ac962025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.d3b6669e-479f-4bc1-b533-5e9a0cc652132025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.e42a22ef-1035-4dd0-94b0-43625542d5842025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.3dca05de-cf63-4ca0-88be-473ea637e6b42025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.d6149dfd-f2a5-4bbd-913c-6a95efe5ffd22025-01-09WarningsExact identifier
application number: M022
Tiger Supply Inc Topical AnestheticBENZOCAINETiger Supply Inc.c6eda1de-4490-4a28-8a31-cbf3e102e74e2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc4261cd90-5087-44a3-bef9-72d33dbf0dfd2025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Ince70240a8-fa9d-4005-a3a0-5cca6188bf612025-01-09WarningsExact identifier
application number: M022
Comfortcaine Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incfda3d254-e103-4be9-9086-51ad022b2b3f2025-01-09WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalc161da79-9ea5-4c7f-890c-4315129fe5bf2025-01-08WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1200-17067712000159 mL in 1 BOTTLE, GLASS (70677-1200-1) 59 ml2024-12-17NoNoCurrent