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 |
|---|---|---|---|---|---|---|
| Astra-dent Topical Anesthetic Gel | BENZOCAINE | Zag Usa Inc | f2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee | 2025-01-09 | Warnings | M022 |
| Burkhart | STANNOUS FLUORIDE | Burkhart Dental Supply Inc | 6d8078e9-b0d8-4220-b90a-3f14fa0e43f4 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 26128466-939b-445f-aa64-04c7283d306c | 2025-01-09 | Warnings | M022 |
| Burkhart | STANNOUS FLUORIDE | Burkhart Dental Supply Inc | 048c9978-e32e-4f77-9a4e-40acd5fcdfaf | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | aa09dcc0-e641-4c6d-8a84-ba890c0fce4c | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 4255da05-d264-4a4c-bd67-53d4862c0682 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 2282ea74-94c1-40be-a77f-290763a76250 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 99bce4c6-4593-40a1-b28d-8334a79b9d42 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | aa233c68-c6ac-44a5-b50e-3f5cd843bd25 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | bb11bfb4-1b50-48c6-8273-452b47b47833 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | 867cef7b-fe6e-4a45-87c1-35579a681c6c | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | c6238079-0bcc-4c35-9b73-455252d41ee5 | 2025-01-09 | Warnings | M022 |
| Burkhart Topical Anesthetic | BENZOCAINE | Burkhart Dental Supply Inc | b144aca9-91d1-4106-a39c-b928192ad41e | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | edcb8451-6fa7-4bc2-95f6-2a0806f7f3da | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | 576660ed-203a-4842-9d39-c5be10daf976 | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | 1796b3ec-833a-4cf1-ba50-bc4da827f84f | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | d923fa75-f556-45e3-9f52-39a62e89984b | 2025-01-09 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | American Medical & Hospital Supply Co., Inc. | cd3ede8c-2c77-4d81-8dff-8198025a2156 | 2025-01-09 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | cb7f5f9b-4192-15e6-e053-2995a90a6457 | 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 |