Gentian Violet
- Product NDC
- 73635-1219
- 11-digit product format
- 736351219
- Labeler code
- 73635
- Product ID
- 73635-1219_5d6d8686-0826-5e30-e063-6394a90a7825
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Gentian Violet 1%
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Germa Products, LLC
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-29
- Substance
- GENTIAN VIOLET
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 73635-1219 | D | Discontinued by firm | 2026-10-23 | ||
| excluded package | package | 73635-1219 | 73635-1219-1 | D | Discontinued by firm | 2026-10-23 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 73635-1219-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 73635-1219-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 73635-1219-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 73635-1219-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 73635-1219-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 73635-1219-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 73635-1219-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 73635-1219-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 73635-1219-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 73635-1219-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 73635-1219-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 73635-1219-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Brand name suffix
- Anti-Infective
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GENTIAN VIOLET | 10 mg/mL |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-05-09 | Gentian Violet Antiseptic |
| 2023-05-09 | Gentian Violet Antiseptic |
| 2023-05-09 | Gentian Violet Antiseptic |
| 2023-01-30 | Gentian Violet Antiseptic |
| 2023-01-30 | Gentian Violet Antiseptic |
| 2023-01-30 | Gentian Violet Antiseptic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73635-1219-1 | Gentian VioletAnti-Infective | 29.62 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 29.62 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73635-1219 | GENTIAN VIOLET ANTI-INFECTIVE (GENTIAN VIOLET 1%) LIQUID [GERMA PRODUCTS, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241017_bf7824f0-8a4f-a063-e053-2995a90ae9a1.zip |
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 |
|---|---|---|---|---|---|---|
| Safly BZK Antiseptic Towelette | BENZALKONIUM CHLORIDE | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 5cd9043e-daf2-43eb-9568-54775fc4f84a | 2024-05-15 | Warnings | M003 |
| Noshinku Bergamot Hand Sanitizer | ALCOHOL | Noshinku | 53fea81e-4482-6fae-e054-00144ff8d46c | 2024-05-14 | Warnings | M003 |
| Noshinku Eucalyptus Hand Sanitizer | ALCOHOL | Noshinku | 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 | 2024-05-14 | Warnings | M003 |
| Noshinku Lavender Hand Sanitizer | ALCOHOL | Noshinku | a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf | 2024-05-14 | Warnings | M003 |
| LEADER 2% Mild Iodine Tincture | IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID | Cardinal Health, 110 dba Leader | 7f810b92-60f6-2f72-e053-2991aa0ab973 | 2024-05-13 | Warnings | M003 |
| Leader Decolorized Iodine | ALCOHOL LIQUID | Cardinal Health, 110 dba Leader | 822f6f28-956f-dd82-e053-2991aa0ae752 | 2024-05-13 | Warnings | M003 |
| Inverness Ear Care | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 180a2995-334c-2e93-e063-6294a90aecf7 | 2024-05-09 | Warnings | M003 |
| Helzberg Diamonds Ear Care | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 180a3776-0edd-26f3-e063-6294a90a740d | 2024-05-09 | Warnings | M003 |
| Ulta Beauty Ear Care | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 180a37f4-8718-3e40-e063-6294a90acaad | 2024-05-09 | Warnings | M003 |
| Guardian Vaginal | BENZALKONIUM CHLORIDE | Eastern Century Pharmaceuticals | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 2024-04-24 | Warnings | M003 |
| Inverness Hygienic Ear Care Antiseptic | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b | 2024-04-18 | Warnings | M003 |
| Lovisa Piercing Care Solution | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 | 2024-04-18 | Warnings | M003 |
| CliniClean BZK Cleansing Contains Benzalkonium Chloride | BENZALKONIUM CHLORIDE | HR HealthCare | b6916466-0931-408f-a430-0797a449c32e | 2024-04-18 | Warnings | M003 |
| Handy Solutions First Aid Kit | BENZALKONIUM CHLORIDE | Navajo Manufacturing Company Inc. | 130237ff-3db4-1288-e063-6394a90ab1af | 2024-04-16 | Warnings | M003 |
| BZK | BENZALKONIUM CHLORIDE | Henry Schein Inc. | ff877b63-fa58-4770-a882-694eda33203b | 2024-04-02 | Warnings | M003 |
| First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d | 2024-04-01 | Warnings | M003 |
| Antiseptic Towelette TOALLITAS ANTISEPTICAS | BENZALKONIUM CHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | b267e186-cf7a-458f-9c28-a48a8554af40 | 2024-04-01 | Warnings | M003 |
| Antiseptic Povidone Iodine Prep Pad | POVIDONE-IODINE | M-star (Hubei) Health&Care Products Co., Ltd. | fc76c1f3-b48e-4276-890d-5b8e5a894e62 | 2024-04-01 | Warnings | M003 |
| Novex Hand Sanitizer | BENZALKONIUM CHLORIDE | Natural Essentials, Inc. | 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3 | 2024-03-20 | Warnings | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE 0.13% | Trifecta Pharmaceuticals USA, LLC. | 13f1c70f-3b44-8eef-e063-6294a90af634 | 2024-03-18 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310481 | gentian violet 1 % Topical Solution | PSN | bf7824f0-8a4f-a063-e053-2995a90ae9a1 | 6 |
| 310481 | gentian violet 10 MG/ML Topical Solution | SCD | bf7824f0-8a4f-a063-e053-2995a90ae9a1 | 6 |
| 310481 | gentian violet 1 % Topical Solution | SY | bf7824f0-8a4f-a063-e053-2995a90ae9a1 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 73635-1219-1 | 73635121901 | 29.62 mL in 1 BOTTLE, WITH APPLICATOR (73635-1219-1) | 29.62 ml | 2021-03-29 | 0000-00-00 | No | No | Current |