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 |
|---|---|---|---|---|---|---|
| Antibiotic Application | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | da436c35-a98f-4df7-9d23-885564734cef | 2025-01-13 | Warnings | M003 |
| Burn Treatment | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 2025-01-13 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | CMC Group Inc. | dcca50e6-0935-401d-a23e-be4d1231dde9 | 2025-01-13 | Warnings | M003 |
| Refill 2 | BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | 45dde3f0-546c-4ec5-beb0-c3d0432f4983 | 2025-01-13 | Warnings | M003 |
| Refill 3 | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | e5cb395f-5037-4b0e-9c9d-2d78b5b01b25 | 2025-01-13 | Warnings | M003 |
| Refill 4 | ISOPROPYL ALCOHOL | CMC Group Inc. | 6f4a4538-7522-4bcf-b3cf-8dea60438a4d | 2025-01-13 | Warnings | M003 |
| Refill 6 | ALCOHOL, WATER | CMC Group, Inc. | 7849ae59-5484-4b86-a0b9-ec9b93d9afe0 | 2025-01-13 | Warnings | M003 |
| EVR Povidone lodine Wipe | POVIDONE LODINE | Changzhou Maokang Medical Products Co., Ltd. | 2b57e301-74e0-e1db-e063-6294a90a6c18 | 2025-01-10 | Warnings | M003 |
| EVR Sting Relief Wipe | BENZOCAINE, ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 2b584d09-916c-00f8-e063-6294a90adbcf | 2025-01-10 | Warnings | M003 |
| Medzah Ditek Alcohol Prep Pads | ISOPROPYL ALCOHOL | Medzah Industries | 4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac | 2025-01-10 | Warnings | M003 |
| Alcohol Prep Pad-Large | ISOPROPYL ALCOHOL | Global Biomedical Technologies, LLC | 93d00515-e93f-48a3-b66b-7d933e734e54 | 2025-01-10 | Warnings | M003 |
| DERMADIVE ULTRACARE - TETRAID | BENZALKONIUM CHLORIDE | Releaf Technologies LLC | 025c0b33-73ca-334b-e063-6394a90ad668 | 2025-01-09 | Warnings | M003 |
| Drs. pharmacy triple antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT | OL PHARMA TECH, LLC | bb730976-0045-c0ae-e053-2a95a90af34e | 2025-01-09 | Warnings | M003 |
| Drs. Antibiotic Bacitracin | BACITRACIN | OL PHARMA TECH, LLC | c26493c4-0bc1-5fdc-e053-2995a90a81e6 | 2025-01-09 | Warnings | M003 |
| Drs. Pharmacy Triple Antibiotic Plus | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE | OL PHARMA TECH, LLC Drs PHARMACY | d037bfb8-0d8c-4eda-e053-2995a90ae1f2 | 2025-01-09 | Warnings | M003 |
| BACTINE MAX | BACTINE MAX WOUND WASH | WellSpring Pharmaceutical Corporation | 39b26c28-93e0-41a9-8018-f73525ebc015 | 2025-01-08 | Warnings | M003 |
| sterile | POVIDONE-IODINE | Asia Dynamics Inc., d/b/a ADI Medical | 0658a0c8-f5ec-b380-e063-6394a90afff5 | 2025-01-08 | Warnings | M003 |
| Betadine Surgical Scrub | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 2025-01-06 | Warnings | M003 |
| First Aid Antiseptic | BENZALKONIUM CHLORIDE | Water-Jel Technologies | 2b3cb958-c0c4-47fd-8338-7c7821135f2b | 2025-01-06 | Warnings | M003 |
| Instant Hand Sanitizer | ALCOHOL | Water-Jel Technologies | 54e62104-8076-41db-afe5-6dc5c3563acc | 2025-01-06 | 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 |