Gel Antiseptico Dermowipe
- Product NDC
- 58345-103
- 11-digit product format
- 583450103
- Labeler code
- 58345
- Product ID
- 58345-103_2b26aa61-8365-58d9-e063-6294a90ae76b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Gel antiseptico a base de alcohol etilico
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Key Qu�mica S.A. de C.V.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-05
- Substance
- ALCOHOL
- Active strength
- 70 mL/70mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gel Antiseptico Dermowipe
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALCOHOL | 70 mL/70mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3K9958V90M |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58345-103-01 | Gel Antiseptico Dermowipe | 12 in 1 BOX | GEL | 12 | | 2 |
| 58345-103-01 | Gel Antiseptico Dermowipe | 300 mL in 1 BOTTLE, PUMP | GEL | 300 | | 2 |
| 58345-103-02 | Gel Antiseptico Dermowipe | 960 mL in 1 BOTTLE, PUMP | GEL | 960 | | 2 |
| 58345-103-02 | Gel Antiseptico Dermowipe | 6 in 1 BOX | GEL | 6 | | 2 |
| 58345-103-03 | Gel Antiseptico Dermowipe | 6 in 1 BOX | GEL | 6 | | 2 |
| 58345-103-03 | Gel Antiseptico Dermowipe | 800 mL in 1 BAG | GEL | 800 | | 2 |
| 58345-103-04 | Gel Antiseptico Dermowipe | 3 in 1 BOX | GEL | 3 | | 2 |
| 58345-103-04 | Gel Antiseptico Dermowipe | 1000 mL in 1 BOTTLE | GEL | 1000 | | 2 |
| 58345-103-05 | Gel Antiseptico Dermowipe | 4 in 1 BOX | GEL | 4 | | 2 |
| 58345-103-05 | Gel Antiseptico Dermowipe | 4000 mL in 1 BOTTLE | GEL | 4000 | | 2 |
| 58345-103-06 | Gel Antiseptico Dermowipe | 20000 mL in 1 BOTTLE | GEL | 20000 | | 2 |
| 58345-103-07 | Gel Antiseptico Dermowipe | 1000 mL in 1 BOTTLE, PUMP | GEL | 1000 | | 2 |
| 58345-103-07 | Gel Antiseptico Dermowipe | 3 in 1 BOX | GEL | 3 | | 2 |
| 58345-103-08 | Gel Antiseptico Dermowipe | 4000 mL in 1 BOTTLE, PUMP | GEL | 4000 | | 2 |
| 58345-103-08 | Gel Antiseptico Dermowipe | 2 in 1 BOX | GEL | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58345-103 | GEL ANTISEPTICO DERMOWIPE (GEL ANTISEPTICO A BASE DE ALCOHOL ETILICO) GEL [KEY QUÍMICA S.A. DE C.V.] | 2 | Current NDC, 15 package rows | 20250109_15620afc-d6ae-0f34-e063-6294a90a8ad2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58345-103-01 | 58345010301 | 12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMP | | 2024-04-05 | No | No | Current |
| 58345-103-02 | 58345010302 | 6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMP | | 2024-04-05 | No | No | Current |
| 58345-103-03 | 58345010303 | 6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAG | 6 bag | 2024-04-05 | No | No | Current |
| 58345-103-04 | 58345010304 | 3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLE | 3 bottle | 2024-04-05 | No | No | Current |
| 58345-103-05 | 58345010305 | 4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLE | 4 bottle | 2024-04-05 | No | No | Current |
| 58345-103-06 | 58345010306 | 20000 mL in 1 BOTTLE (58345-103-06) | 20000 ml | 2024-04-05 | No | No | Current |
| 58345-103-07 | 58345010307 | 3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMP | | 2024-04-05 | No | No | Current |
| 58345-103-08 | 58345010308 | 2 BOTTLE, PUMP in 1 BOX (58345-103-08) / 4000 mL in 1 BOTTLE, PUMP | | 2024-04-05 | No | No | Current |