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 |
|---|---|---|---|---|---|---|
| Avant | BENZOCAINE | Dharma Research, Inc. | fc8194af-2e77-4ad1-ae75-461dce3ed604 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | baf7d184-07ed-4491-a1fc-9a377b4b0110 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 033034af-c86c-4dbf-90eb-009c117024c6 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | 658ada18-2334-4b4e-b08e-702fa127aa14 | 2023-10-11 | Warnings | M022 |
| Avant | BENZOCAINE | Dharma Research, Inc. | cad932e5-8d7f-4f20-b1c2-febd328152f0 | 2023-10-11 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 2c9519ab-320d-49da-9deb-97a6168fb088 | 2023-10-10 | Warnings | M022 |
| Ioline | BENZOCAINE | Dharma Research, Inc. | b862c974-c024-42c3-986e-b65069437c7b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 651ea978-081d-4c59-b177-6049a69d9415 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | db763237-2910-45b9-be72-da092edc951b | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 34316f93-10b4-41cc-8654-625283f0044c | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 142a8824-657e-492a-8e5a-b15eb73383c9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | 414cbec9-94e2-4bca-908b-1e79f8db0b27 | 2023-10-10 | Warnings | M022 |
| Sore throat cherry | PHENOL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | de634cf1-ed39-4d8a-8855-006c69b7aee9 | 2023-10-10 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | 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 |