Gentian Violet
- Product NDC
- 69469-010
- 11-digit product format
- 694690010
- Labeler code
- 69469
- Product ID
- 69469-010_59f83eee-0ef4-754f-e063-6294a90a1547
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Gentian Violet
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Vitamex USA, Corp
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-03
- Substance
- GENTIAN VIOLET
- Active strength
- 10 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
- Gentian Violet
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GENTIAN VIOLET | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J4Z741D6O5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310481 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 21742061-fc0b-f750-e063-6394a90a7508 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69469-010-01 | 2026-01-29 | C162847 | 48780-1 | 49896155-ac2c-586f-e063-e6dba90add90 | Gentian Violet 1oz |
| 69469-010-01 | 2026-01-29 | C162847 | 48780-1 | 49896155-ac2c-586f-e063-e6dba90add90 | Gentian Violet 1oz |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69469-010-01 | Gentian Violet | 30 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 30 | 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 |
|---|---|---|---|---|---|---|
| Unguentine | PHENOL, ZINC OXIDE | Oakhurst Company | 327038a1-b825-1199-e063-6394a90a7f5f | 2025-04-10 | Warnings | M003 |
| Northside Hospital Grey Amenity Kit | SODIUM MONOFLUOROPHOSPATE | ASP Global, LLC | a3cc89df-be1b-4d9a-8ba3-857885325422 | 2025-04-09 | Warnings | M003 |
| Isopropyl alcohol 70 percent | ISOPROPYL ALCOHOL | TOP CARE (Topco Associates LLC) | afe23634-27a4-46cf-b428-8fa3a274712c | 2025-04-09 | Warnings | M003 |
| Isopropyl Alcohol 91 percent | ISOPROPYL ALCOHOL | TOP CARE (Topco Associates LLC) | 3c70ba1c-b12f-4a98-b993-1179ebe3e070 | 2025-04-09 | Warnings | M003 |
| Band Aid Antiseptic Cleansing | BENZALKONIUM CHLORIDE | Kenvue Brands LLC | d3190050-d646-5957-e053-2995a90ad521 | 2025-04-08 | Warnings | M003 |
| mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01 | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 322b90e8-be38-7237-e063-6394a90a488f | 2025-04-07 | Warnings | M003 |
| Meijer Hydrating Hand Sanitizer 1oz - Watermelon | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 322c0bdd-4dc5-52e7-e063-6294a90a1380 | 2025-04-07 | Warnings | M003 |
| Meijer Hydrating Hand Sanitizer 1oz - Berry | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 322c56b0-7eb6-c33a-e063-6394a90a15fb | 2025-04-07 | Warnings | M003 |
| Meijer Hydrating Hand Sanitizer 1oz - Vanilla | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 322ce179-c528-0f62-e063-6394a90ac560 | 2025-04-07 | Warnings | M003 |
| MEDI-FIRST First Aid Antiseptic | HYDROGEN PEROXIDE | Ultra Distributors Inc | b6f7b346-3d6b-5953-e053-2995a90a878f | 2025-04-07 | Warnings | M003 |
| MEDI-FIRST First Aid Antiseptic | ISOPROPYL ALCOHOL | Ultra Distributors Inc | b6c88941-9982-3a37-e053-2995a90a8a5a | 2025-04-07 | Warnings | M003 |
| Walgreens Max Strength Burn Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Walgreens Co. | 25a1e89b-bafd-4770-e063-6294a90a14d2 | 2025-04-07 | Warnings | M003 |
| Eye Wash | WATER | CMC Group Inc. | 6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561 | 2025-04-02 | Warnings | M003 |
| Standard ANSI First Aid | WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE | CMC Group, Inc. | e1ef74bf-8895-4200-a411-f726dcdaa945 | 2025-04-02 | Warnings | M003 |
| Clear Defense | ETHYL ALCOHOL | Melaleuca, Inc. | a2178a68-780e-e69b-e053-2a95a90ab7d6 | 2025-04-02 | Warnings | M003 |
| Large ANSI First Aid Kit | WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE | CMC Group, Inc. | fa8578c2-a0bc-4e2e-a4f9-d48debfff378 | 2025-04-02 | Warnings | M003 |
| ETHYL ALCOHOL | ALCOHOL | ASP Global LLC | 67a4b949-ce8a-4841-a965-fcc94165135c | 2025-04-02 | Warnings | M003 |
| Sanitizing Hand Mist | ETHYL ALCOHOL | ALO New York LLC | 31baefe1-2521-9ef3-e063-6294a90a450e | 2025-04-01 | Warnings | M003 |
| Deconimo | HAND SANITIZING WIPES | IMAGINE AMAZON LLC | 311c670d-8f87-b746-e063-6294a90afd5e | 2025-04-01 | Warnings | M003 |
| Meijer Antibacterial Foaming Hand Wash | 0.13% BENZALKONIUM CHLORIDE SOLUTION | Meijer, Inc. | 1eb6b603-ef96-dfda-e063-6294a90ae468 | 2025-03-31 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310481 | gentian violet 1 % Topical Solution | PSN | 21742061-fc0b-f750-e063-6394a90a7508 | 1 |
| 310481 | gentian violet 10 MG/ML Topical Solution | SCD | 21742061-fc0b-f750-e063-6394a90a7508 | 1 |
| 310481 | gentian violet 1 % Topical Solution | SY | 21742061-fc0b-f750-e063-6394a90a7508 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69469-010-01 | 69469001001 | 30 mL in 1 BOTTLE, WITH APPLICATOR (69469-010-01) | 30 ml | 2024-09-03 | No | No | Current |