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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a893a232-2ea8-4e0d-8cbf-7f5040b3be2e	Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0243-16	ML - Milliliter	0395-0243	9a0811d7-af7f-4bc9-9bf4-0b4e83a5eef9	1	2013-10-17
0395-0243-92	ML - Milliliter	0395-0243	b7ef01a6-f854-4be0-8215-1c72658733fc	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOIN RESIN	ACTIVE INGREDIENT	GK21SBA74R	BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]	1
BENZOIN RESIN	ACTIVE MOIETY	GK21SBA74R	BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]	1
ALOE	INACTIVE INGREDIENT	V5VD430YW9	BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]	1
TOLU BALSAM	INACTIVE INGREDIENT	TD2LE91MBE	BENZOIN COMPOUND TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.]	1

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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GuruNanda Oxyfusion	HYDROGEN PEROXIDE	GURUNANDA, LLC	3be317b9-a5d8-b198-e063-6394a90af985	2025-11-11	Warnings	Exact identifier application number: M022
GuruNanda Oral Pain Relief	MENTHOL	GURUNANDA, LLC	3b8f3562-0e46-bea4-e063-6294a90adb71	2025-11-11	Warnings	Exact identifier application number: M022
TopCare Cherry Flavor	PHENOL	TOPCO ASSOCIATES, LLC	5d3f0610-deb4-4180-ae19-2c65ed2f368b	2025-11-10	Warnings	Exact identifier application number: M022
Topcare Sore Throat Menthol Flavor	PHENOL	TOPCO ASSOCIATES LLC	fb1f2c11-2508-4985-bae5-7d547bd6aa23	2025-11-10	Warnings	Exact identifier application number: M022
Zilactin-B	BENZOCAINE	ASCENT CONSUMER PRODUCTS, INC	42eeb3d4-bac6-4e29-e063-6294a90a644d	2025-11-06	Warnings	Exact identifier application number: M022
Zilactin Early Relief Cold Sore	BENZYL ALCOHOL	ASCENT CONSUMER PRODUCTS, INC	42ef8bfa-c4d9-01cf-e063-6394a90ac88a	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	106b6115-d043-4050-80c6-1d82456dea02	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	4c278122-2643-46bf-9e44-11985210a16e	2025-11-06	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fee9969d-ad1a-4f44-9741-a0a44c9e1128	2025-11-06	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	Target Corporation	0ddf9945-147d-4b25-98a6-4e9f12a4656f	2025-11-05	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	e6a312e5-17ac-46f0-8723-4e40eeecd69f	2025-11-04	Warnings	Exact identifier application number: M022
PEROXY SHIELD MOUTH SORE	1.5% HYDROGEN PEROXIDE	Dental Technologies, Inc.	a72e433b-1b7d-4a0c-e053-2995a90a30c4	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ae628766-25b7-4b4f-abb8-a43faf2f44b9	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	719743f9-21fc-4568-b879-acdfa4639464	2025-11-04	Warnings	Exact identifier application number: M022
Alpha-Caine Topical Anesthetic	BENZOCAINE	Dental Technologies, Inc.	ff0695a1-1d7d-4b51-97fd-689e56d914fe	2025-11-04	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f7edf75c-cdba-4dde-bfc5-a04af34759d3	2025-11-03	Warnings	Exact identifier application number: M022
7 Select Oral Pain Maximum Strength Relief	BENZOCAINE	7-ELEVEN, INC.	f170a570-1c50-4b9a-be16-9b01bf5eaa74	2025-10-31	Warnings	Exact identifier application number: M022
Oral Pain Relief	BENZOCAINE AND BENZALKONIUM CHLORIDE	Universal Distribution Center LLC	18520f9b-4d35-1e9c-e063-6294a90aaa39	2025-10-30	Warnings	Exact identifier application number: M022
Iodent Oral Analgesic	BENZOCAINE	United Exchange Corp.	63902125-f8dc-0ada-e053-2991aa0a7ce5	2025-10-30	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	BETTER LIVING BRANDS, LLC	3bded237-4d2c-4b38-bedc-267fdc374194	2025-10-29	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GK21SBA74R	BENZOIN RESIN	9000-05-9	BENZOIN RESIN

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Humco Benzoin Compound Tincture, USP	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2025-12-11	HUMAN OTC DRUG LABEL	7