Isagel
- Product NDC
- 11701-025
- 11-digit product format
- 117010025
- Labeler code
- 11701
- Product ID
- 11701-025_48028c1c-0707-4208-8c36-ae2b25f3a59d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alcohol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Coloplast Corp
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-06-15
- Marketing end
- 2026-11-30
- Substance
- ALCOHOL
- Active strength
- 600 mL/1000mL
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isagel
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALCOHOL | 600 mL/1000mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3K9958V90M |
| Rxcui | 581658 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11701-025-04 | Isagel | 118 mL in 1 BOTTLE | GEL | 118 | | 13 |
| 11701-025-26 | Isagel | 621 mL in 1 BOTTLE | GEL | 621 | | 13 |
| 11701-025-45 | Isagel | 800 mL in 1 BAG | GEL | 800 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Alcohol | ACTIVE INGREDIENT | 3K9958V90M | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| Alcohol | ACTIVE MOIETY | 3K9958V90M | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| GLYCERETH-26 | INACTIVE INGREDIENT | NNE56F2N14 | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 7 | |
| ALCOHOL | ACTIVE INGREDIENT | 3K9958V90M | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
| ALCOHOL | ACTIVE MOIETY | 3K9958V90M | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
| GLYCERETH-26 | INACTIVE INGREDIENT | NNE56F2N14 | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11701-025 | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20231216_eba7e574-25c2-445a-98f6-2d1045455466.zip |
| 11701-025 | ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20231216_5be93a24-c644-4e6b-a600-87f0a5a09e5c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11701-025-04 | 11701002504 | 118 mL in 1 BOTTLE (11701-025-04) | 118 ml | 2009-06-15 | 0000-00-00 | No | No | Current |
| 11701-025-26 | 11701002526 | 621 mL in 1 BOTTLE (11701-025-26) | 621 ml | 2009-06-15 | 2026-11-30 | No | No | Current |
| 11701-025-45 | 11701002545 | 800 mL in 1 BAG (11701-025-45) | 800 ml | 2009-06-15 | 0000-00-00 | No | No | Current |