Home NDC 0395-0247 Benzoin Tincture
Product NDC 0395-0247
11-digit product format 003950247
Labeler code 0395
Product ID 0395-0247_0c929258-b192-bc2f-e063-6394a90a8e47
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 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 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 0395-0247-92 Benzoin Tincture 59 mL in 1 BOTTLE, PLASTIC LIQUID 59 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0247 BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231216_b33b5896-673b-498c-8a58-76ece8552f7a.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 20 of 39 · 779 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anestenka BENZOCAINE Menper Distributors, Inc 00a3f1bc-ddfe-47c6-8221-f48f91513503 2025-07-22 Warnings Exact identifier application number: M022 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier application number: M022 SprinJene Natural Sensitivity and Gum POTASSIUM NITRATE Health and Natural Beauty USA Corp 3cb23e36-0e8c-4172-b4ae-859b58a2739f 2025-07-07 Warnings Exact identifier application number: M022 Normal Salt SODIUM CHLORIDE Twin Med LLC dc82ff0f-8600-373a-e053-2995a90a7505 2025-07-03 Warnings Exact identifier application number: M022 Sensodyne Pronamel Kids Berry Twist SODIUM FLUORIDE Haleon US Holdings LLC 69c07c36-b5e0-420b-ab29-7d1091386322 2025-07-03 Warnings Exact identifier application number: M022 DenTek Instant Pain Relief Maximum Strength BENZOCAINE DenTek Oral Care, Inc. ae92b76e-815a-4b4c-8128-bd045098caa5 2025-06-30 Warnings Exact identifier application number: M022 Sensodyne Clinical White Stain Protector POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 99037e59-53d6-492c-8fce-67641fc8efdd 2025-06-25 Warnings Exact identifier application number: M022 Iolite-S BENZOCAINE Dharma Research, Inc. b3b68914-2adc-4f07-9521-0b18756be522 2025-06-14 Warnings Exact identifier application number: M022 Red Cross Toothache EUGENOL The Mentholatum Company 3537e599-65d9-48d6-8a46-d42312f71e84 2025-06-11 Warnings Exact identifier application number: M022 QUALITY CHOICE Sore Throat PHENOL CHAIN DRUG MARKETING ASSOCIATION c95ee086-f384-475d-ad0c-75518cb9d2fe 2025-06-10 Warnings Exact identifier application number: M022 Onral Oral Pain Reliever Mouthwash BENZOCAINE Syka Pharma Inc. 5dd8d933-6f32-4eaf-8eca-9365d7de55a2 2025-06-03 Warnings Exact identifier application number: M022 Orajel Rescue Relief Pen ORAL PAIN RELIEVER Church & Dwight Co., Inc. 2d68eec5-ae8a-9cdf-e063-6294a90a9799 2025-06-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 9e1f7462-a052-4db4-bc59-cce437b695d0 2025-05-20 Warnings Exact identifier application number: M022 Saline 1.5 FL OZ SALINE ALAINA HEALTHCARE PRIVATE LIMITED f1bdbb25-6943-4828-9ae0-7d9783c18b5f 2025-05-19 Warnings Exact identifier application number: M022 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY WORLD DENTISTS ASSOCIATION AMERICA LIMITED 3573f149-2af9-4c86-e063-6294a90a7b3f 2025-05-18 Warnings Exact identifier application number: M022 Hydrogen Peroxide HYDROGEN PEROXIDE Safeway, Inc. 8fe2f1df-3264-455d-b62c-953dce171c02 2025-05-16 Warnings Exact identifier application number: M022 Parodontax Active Gum Health Daily Mouthwash Breath Freshener CETYLPYRIDINIUM CHLORIDE Haleon US Holdings LLC 32b632bf-058d-447b-a7fb-a9dd05c1e2b8 2025-05-08 Warnings Exact identifier application number: M022 Parodontax Active Gum Health Clear Mint CETYLPYRIDINIUM CHLORIDE Haleon US Holdings LLC 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 2025-05-08 Warnings Exact identifier application number: M022 Listerine Clinical Solutions Gum Health Icy Mint EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Kenvue Brands LLC 06e1122b-1100-43c0-e063-6394a90a2e78 2025-04-22 Warnings Exact identifier application number: M022 Hydrogen Peroxide HYDROGEN PEROXIDE Strategic Sourcing Services LLC 5260258a-bb1e-43d6-bce1-70a38778a64a 2025-04-14 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-0247-92 00395024792 59 mL in 1 BOTTLE, PLASTIC (0395-0247-92) 59 ml 2017-11-10 0000-00-00 No No Current