Antiseptic Skin Cleanser
- Product NDC
- 0116-0161
- 11-digit product format
- 001160161
- Labeler code
- 0116
- Product ID
- 0116-0161_34004103-dcc3-511c-e063-6394a90a270d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorhexidine Gluconate 4%
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Xttrium Laboratories, Inc.
- Application
- NDA019125
- Marketing category
- NDA
- Marketing start
- 2011-05-01
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 4 mg/100mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antiseptic Skin Cleanser
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORHEXIDINE GLUCONATE | 4 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MOR84MUD8E |
| Rxcui | 211365 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0116-0161-08 | Antiseptic Skin Cleanser | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | | 9 |
| 0116-0161-15 | Antiseptic Skin Cleanser | 15 mL in 1 KIT | LIQUID | 15 | | 9 |
| 0116-0161-16 | Antiseptic Skin Cleanser | 473 mL in 1 BOTTLE, PUMP | LIQUID | 473 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0116-0161 | ANTISEPTIC SKIN CLEANSER (CHLORHEXIDINE GLUCONATE 4%) LIQUID [XTTRIUM LABORATORIES, INC.] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250503_4ab2cfc2-7adb-20c4-e054-00144ff8d46c.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 |
|---|
| 0116-0161-08 | 00116016108 | 237 mL in 1 BOTTLE, PLASTIC (0116-0161-08) | 237 ml | 2011-05-01 | 0000-00-00 | No | No | Current |
| 0116-0161-15 | 00116016115 | 15 mL in 1 KIT (0116-0161-15) | 15 ml | 2017-01-01 | 0000-00-00 | No | No | Current |
| 0116-0161-16 | 00116016116 | 473 mL in 1 BOTTLE, PUMP (0116-0161-16) | 473 ml | 2011-05-01 | 0000-00-00 | No | No | Current |