Home NDC 0395-0243 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 Ingredient Strength BENZOIN RESIN 1000 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GK21SBA74R Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-0243-16 Benzoin Compound Tincture 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 7 0395-0243-92 Benzoin Compound Tincture 59 mL in 1 BOTTLE, PLASTIC LIQUID 59 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0243 BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20231216_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 32 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-0243-16 00395024316 473 mL in 1 BOTTLE, PLASTIC (0395-0243-16) 473 ml 2017-11-10 0000-00-00 No No Current 0395-0243-92 00395024392 59 mL in 1 BOTTLE, PLASTIC (0395-0243-92) 59 ml 2017-11-10 0000-00-00 No No Current