Skin antisepsis, oral cleansing, nasal antisepsis
- Product NDC
- 53462-007
- 11-digit product format
- 534620007
- Labeler code
- 53462
- Product ID
- 53462-007_8a0dae43-bec9-3b38-e053-2a95a90a236b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CHLORHEXIDINE GLUCONATE
- Dosage form
- KIT
- Labeler
- Sage Products LLC
- Application
- NDA021669
- Marketing category
- NDA
- Marketing start
- 2012-02-06
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53462-003-15 | Skin antisepsis, oral cleansing, nasal antisepsis | 15 mL in 1 BOTTLE | LIQUID | 15 mL | 1.2 mg in 1mL | 3 |
| 53462-007-27 | Skin antisepsis, oral cleansing, nasal antisepsis | 1 in 1 KIT | KIT | 1 | | 3 |
| 53462-705-23 | Skin antisepsis, oral cleansing, nasal antisepsis | 6 in 1 PACKAGE | CLOTH | 6 | 500 mg | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| chlorhexidine gluconate | ACTIVE INGREDIENT | MOR84MUD8E | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| chlorhexidine | ACTIVE MOIETY | R4KO0DY52L | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| aloe vera leaf | INACTIVE INGREDIENT | ZY81Z83H0X | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| dimethicone 350 | INACTIVE INGREDIENT | 2Y53S6ATLU | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| gluconolactone | INACTIVE INGREDIENT | WQ29KQ9POT | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| LAURAMIDOPROPYLAMINE OXIDE | INACTIVE INGREDIENT | I6KX160QTV | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| MALIC ACID | INACTIVE INGREDIENT | 817L1N4CKP | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| nonoxynol-9 | INACTIVE INGREDIENT | 48Q180SH9T | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| PEG-40 SORBITAN DIISOSTEARATE | INACTIVE INGREDIENT | JL4CCU7I1G | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| SACCHARIN SODIUM DIHYDRATE | INACTIVE INGREDIENT | SB8ZUX40TY | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| SODIUM IODIDE | INACTIVE INGREDIENT | F5WR8N145C | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53462-007 | SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS (CHLORHEXIDINE GLUCONATE) KIT [SAGE PRODUCTS LLC] | 3 | Legacy NDC, 3 package rows | 20190530_6ea1691d-5379-f0c0-1b37-ecf08f6dbc00.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 53462-003-15 | 53462000315 | 15 mL in 1 BOTTLE | 15 ml | Historical |
| 53462-007-27 | 53462000727 | 1 in 1 KIT | | Historical |
| 53462-705-23 | 53462070523 | 6 in 1 PACKAGE | | Historical |