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 |
|---|---|---|---|---|---|---|
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health, Inc | bb7c530f-5d80-4158-b715-09c1c837299d | 2024-11-21 | Warnings | M003 |
| Alcohol sterile | ISOPROPYL ALCOHOL | Cardinal Health 200 LLC | 10135db9-f614-4511-96ac-faa6a02a1b61 | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Swabsticks 4 Triple | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | d9f35c14-2f5a-4e1a-bc2b-a7e163134213 | 2024-11-21 | Warnings | M003 |
| Povidone-lodine Swabsticks Triple | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 74e70ea9-640b-4295-a40f-56f65fca1300 | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 37f10b1f-b73c-4d71-91c2-1252f3d9d4ce | 2024-11-21 | Warnings | M003 |
| BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | Changzhou Maokang Medical Products Co., Ltd | 1936d749-bf38-a433-e063-6294a90aba8c | 2024-11-21 | Warnings | M003 |
| Maokang 10 Povidone Iodine | POVIDONE-IODINE | Changzhou Maokang Medical Products Co., Ltd | 7c17ce40-0358-44ff-aa60-53711666914b | 2024-11-21 | Warnings | M003 |
| MK Alcohol Prep Pads Medium | ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd | 11390854-9e72-40a2-9c89-3c29a585dced | 2024-11-21 | Warnings | M003 |
| Instant Hand Sanitizeing Wipe | ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS | Shandong Yayun Sanitary Products Co., Ltd. | aa0dc01a-2c6b-7402-e053-2a95a90af6a2 | 2024-11-21 | Warnings | M003 |
| Dynarex Povidone Iodine Prep Solution | POVIDONE IODINE PREP SOLUTION | Dynarex Corporation | 6bb4d55b-2be7-3549-e053-2a91aa0a2bb0 | 2024-11-20 | Warnings | M003 |
| Dynarex Povidone Iodine Surgical Scrub | POVIDONE IODINE SURGICAL SCRUB SOLUTION | Dynarex Corporation | 6f053e55-cbf6-9072-e053-2991aa0a2edd | 2024-11-20 | Warnings | M003 |
| Dynarex Green | ALCOHOL | Dynarex Corporation | 072572be-49dd-4594-bc40-b56db57ada5b | 2024-11-20 | Warnings | M003 |
| Dynarex Green | CHLOROXYLENOL | Dynarex Corporation | 59b098d2-08de-4fdb-a209-ae226abf37d6 | 2024-11-20 | Warnings | M003 |
| Baby Wipes | PROPYLENE GLYCOL | Shandong Yayun Sanitary Products Co., Ltd. | aeb9a12c-955f-5030-e053-2995a90a2dd6 | 2024-11-20 | Warnings | M003 |
| Pet wipes | BENZALKONIUM CHLORIDE | Shandong Yayun Sanitary Products Co., Ltd. | 2764ea79-32d8-b7f6-e063-6394a90a5501 | 2024-11-20 | Warnings | M003 |
| Premium Hand Sanitizer | ETHANOL | MCKESSON MEDICAL-SURGICAL INC. | a9514466-e0c6-4792-984a-9f07d94ee887 | 2024-11-18 | Warnings | M003 |
| MARVEL BZK ANTISEPTIC WIPE | BENZALKONIUM CHLORIDE | Ashtel Studios, Inc. | 93ed0bb4-834d-44ca-9c0a-20086fc09ab8 | 2024-11-18 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | McKesson Medical-Surgical Inc. | 98b0bcc2-539b-4471-ba98-bbe17bb881bd | 2024-11-15 | Warnings | M003 |
| CVS Health Hydrogen Peroxide Wipes | HYDROGEN PEROXIDE | CVS PHARMACY, INC | 7a930a5e-5b69-428f-9cbb-d03dae180295 | 2024-11-12 | Warnings | M003 |
| First Aid Only Povidone-Iodine Prep Pad | POVIDONE-IODINE | Acme United Corporation | 509b6c8e-6a9f-2656-e054-00144ff8d46c | 2024-11-09 | 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 |