FDA.reportPublic FDA data

Benzoin Compound Tincture

Product NDC
0395-0243
11-digit product format
003950243
Labeler code
0395
Product ID
0395-0243_45b3d3ef-3410-79a1-e063-6394a90a758d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoin Resin
Dosage form
LIQUID
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
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
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
a893a232-2ea8-4e0d-8cbf-7f5040b3be2eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0243-16Benzoin Compound Tincture473 mL in 1 BOTTLE, PLASTICLIQUID4737
0395-0243-92Benzoin Compound Tincture59 mL in 1 BOTTLE, PLASTICLIQUID597

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0243-16ML - Milliliter0395-02439a0811d7-af7f-4bc9-9bf4-0b4e83a5eef912013-10-17
0395-0243-92ML - Milliliter0395-0243b7ef01a6-f854-4be0-8215-1c72658733fc12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOIN RESINACTIVE INGREDIENTGK21SBA74RBENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]1
BENZOIN RESINACTIVE MOIETYGK21SBA74RBENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]1
ALOEINACTIVE INGREDIENTV5VD430YW9BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]1
TOLU BALSAMINACTIVE INGREDIENTTD2LE91MBEBENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0243BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]6Current NDC, Legacy NDC, 2 package rows20231216_a893a232-2ea8-4e0d-8cbf-7f5040b3be2e.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0243-1600395024316473 mL in 1 BOTTLE, PLASTIC (0395-0243-16) 473 ml2017-11-100000-00-00NoNoCurrent
0395-0243-920039502439259 mL in 1 BOTTLE, PLASTIC (0395-0243-92) 59 ml2017-11-100000-00-00NoNoCurrent