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 |
|---|---|---|---|---|---|---|
| Betadine Solution | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 41891599-420e-48d2-8e31-d28a2209e383 | 2025-01-06 | Warnings | M003 |
| Signature Care Alcohol Prep Pad | ISOPROPYL ALCOHOL | Better Living Brands LLC | adc87331-1aa1-3457-e053-2a95a90a7eb1 | 2025-01-03 | Warnings | M003 |
| Alcohol Extra-Thick | ISOPROPYL ALCOHOL | Meijer Distribution Inc | 0b02643d-ea14-4877-ae9c-f0749d1b2d10 | 2025-01-03 | Warnings | M003 |
| Premier Value | ISOPROPYL ALCOHOL | Pharmacy Value Alliance, LLC | d2baa47e-9673-7f23-e053-2a95a90adcb7 | 2025-01-03 | Warnings | M003 |
| CVS Alcohol Prep | ISOPROPYL ALCOHOL | CVS Pharmacy | 88f761c1-cb50-4edc-9a54-43444378eff7 | 2025-01-03 | Warnings | M003 |
| Sterile Alcohol | ISOPROPYL ALCOHOL | Chain Drug Marketing Association Inc | 55922632-3768-4450-9389-ba7d7d91f2c9 | 2025-01-03 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | CASAD Company, Inc | 1e314157-c64e-492a-89ad-2b28831d551d | 2025-01-03 | Warnings | M003 |
| Betadine | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 00002127-02bc-4c66-b0c3-ca29d8224afc | 2025-01-02 | Warnings | M003 |
| ORBIT INNOVATIONS HAND SANITIZER COTTON CANDY | ALCOHOL ANTISEPTIC GEL | Kingkey MBC Life Technology Group Co.,Ltd | 2d02e4d6-8751-b5bc-e063-6394a90a9d97 | 2025-01-01 | Warnings | M003 |
| COVISIDE HAND SANITIZER | ISOPROPYL ALCOHOL | CREAGEN INC | a9f07fcd-4d5c-362c-e053-2a95a90a2e79 | 2024-12-30 | Warnings | M003 |
| KEEPAN A | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | a30679d5-5507-499d-9d9f-498095fd32ac | 2024-12-30 | Warnings | M003 |
| DE LA CRUZ GENTIAN VIOLET | GENTIAN VIOLET | DLC Laboratories, Inc. | d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a7 | 2024-12-30 | Warnings | M003 |
| Alcohol Prep Pad | ISOPROPYL ALCOHOL | R&C Imports LLC | 4e3fe418-d1d9-3024-e054-00144ff88e88 | 2024-12-27 | Warnings | M003 |
| terrasil First Aid Antiseptic Wound and Burn Care | HEXYLRESORCINOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2a2d81c9-5a9f-bb72-e063-6294a90aaf18 | 2024-12-26 | Warnings | M003 |
| ABOVE INTIMATE LIQUIDSOAP | ABOVE INTIMATE | BASTON INDUSTRIA DE AEROSSOIS LTDA | 02f37e55-72fb-532b-e063-6394a90ab0c3 | 2024-12-26 | Warnings | M003 |
| AMERICAN RED CROSS ANTISEPTIC CLEANSING | BENZALKONIUM | MY IMPORTS USA LLC | 2a23da19-aca0-6d86-e063-6394a90ad52e | 2024-12-25 | Warnings | M003 |
| AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOL | ETHYL ALCOHOL | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 2a23ed29-20c3-ab51-e063-6394a90a13a2 | 2024-12-25 | Warnings | M003 |
| AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOL | ETHYL ALCOHOL | MY IMPORTS USA LLC | 2a24bfc4-cf6e-29a4-e063-6394a90afa78 | 2024-12-25 | Warnings | M003 |
| AMERICAN RED CROSS ANTISEPTIC CLEANSING | BENZALKONIUM | Zhejiang Guoyao Jingyue Aerosol Co., Ltd. | 29ff1d68-06f7-e133-e063-6294a90a6154 | 2024-12-24 | Warnings | M003 |
| MedBox Hand Sanitizer | ALCOHOL | Harpers Pharmacy, Inc. | f66c6abe-161c-48fa-8736-0abf97c3799a | 2024-12-20 | 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 |