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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health AdvantageCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyddcd56fe-25d6-8195-e053-2a95a90a575a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dc1f31-625d-a032-e053-2995a90a730d2026-01-08WarningsExact identifier
application number: M022
Crest Pro Health Gum plus Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc598a4ab-5981-0068-e053-2a95a90af4fa2026-01-08WarningsExact identifier
application number: M022
Oral B Gum Detoxify Special Care RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dcdde4-5542-1f87-e053-2995a90a261c2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Fresh MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company62991165-ec81-48a8-e053-2991aa0a54f32026-01-08WarningsExact identifier
application number: M022
Crest Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company6287bc3e-8b05-45d3-e053-2991aa0aaa102026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company8867d791-7e93-4f39-aaaf-bfbee8296fd92026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
application number: M022
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
application number: M022
Scope Icy BlastCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company164ed151-01d3-021a-e063-6294a90a0e512026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Advanced Enamel CareSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1660e7d7-5b8d-8aba-e063-6294a90a50d82026-01-08WarningsExact identifier
application number: M022
Crest Deep Cleanse Germ TreatmentCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company2d6b15d4-7827-ec2f-e063-6294a90a82c82026-01-08WarningsExact identifier
application number: M022
Crest Scope OriginalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company21eed451-9368-146c-e063-6294a90af62b2026-01-08WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
HEB Extra WhiteningFLUORIDEHEBb76c3591-6383-4661-b3db-7a56b11202f72026-01-08WarningsExact 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