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 |
|---|---|
| BENZOIN RESIN | 1000 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| GK21SBA74R | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b33b5896-673b-498c-8a58-76ece8552f7a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-0247-92 | Benzoin Tincture | 59 mL in 1 BOTTLE, PLASTIC | LIQUID | 59 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0395-0247-92 | ML - Milliliter | 0395-0247 | cd06e83d-0c16-4f9b-8625-29d3acb4d04e | 1 | 2013-10-17 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZOIN RESIN | ACTIVE INGREDIENT | GK21SBA74R | BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] | 1 | |
| BENZOIN RESIN | ACTIVE MOIETY | GK21SBA74R | BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] | 1 | |
| ALOE | INACTIVE INGREDIENT | V5VD430YW9 | BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] | 1 | |
| TOLU BALSAM | INACTIVE INGREDIENT | TD2LE91MBE | BENZOIN TINCTURE (BENZOIN RESIN) LIQUID [HUMCO HOLDING GROUP, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | b0e5dc67-da7a-42ac-8657-e8e4da6914be | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721ff57-0111-4bbb-e053-2995a90a1a70 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 8129e871-5f31-4138-ae47-f8978fa6287f | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 0301c1bc-db48-4635-97f5-9eaef7ab9579 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | c0c88180-ccdc-4c48-b262-3ec20d4775d4 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | ba011795-6822-4fff-b9c8-5c91cf9972a7 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 462a5f09-131f-4dfa-a502-547c44e4a4a5 | 2025-01-16 | Warnings | M022 |
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | M022 |
| Kanka Triple Action | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | 078fcdab-38a1-4a9a-bdd3-e17446591ea8 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 9315bd7c-44db-42c8-a9df-aaaa66153c17 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 56185c5f-6f6c-4976-bf18-540b076d90a6 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 88cadb9e-17ab-44bb-b4fe-fcfd6b733465 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | f71b0ab5-0605-4807-b835-903e19aaf2a8 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 37e2d51d-8526-4766-9f15-0ef4bc1f1155 | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | 1c0770a4-5a82-46d4-a660-7553632d749b | 2025-01-09 | Warnings | M022 |
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | f1289991-c809-48cb-8bc1-724bc233dfe9 | 2025-01-09 | Warnings | M022 |
Packages#
| 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 |