Auralyt
- Product NDC
- 53145-311
- 11-digit product format
- 531450311
- Labeler code
- 53145
- Product ID
- 53145-311_3a8ad090-e1c6-7ea7-e063-6394a90a6ffc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbamide Peroxide
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Menper Distributors, Inc
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-01
- Substance
- CARBAMIDE PEROXIDE
- Active strength
- 7.8 mg/12mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Auralyt
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMIDE PEROXIDE | 7.8 mg/12mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31PZ2VAU81 |
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 |
|---|
| 53145-311-04 | Auralyt | 12 mL in 1 BOTTLE, DROPPER | LIQUID | 12 | | 5 |
| 53145-311-04 | Auralyt | 1 in 1 CARTON | LIQUID | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMIDE PEROXIDE | ACTIVE INGREDIENT | 31PZ2VAU81 | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| HYDROGEN PEROXIDE | ACTIVE MOIETY | BBX060AN9V | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| CAMPHOR (NATURAL) | INACTIVE INGREDIENT | N20HL7Q941 | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| EUCALYPTUS OIL | INACTIVE INGREDIENT | 2R04ONI662 | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| SODIUM STANNATE | INACTIVE INGREDIENT | NJ7C1V83KG | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] | 1 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53145-311-04 | 53145031104 | 1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER | 2014-01-01 | 0000-00-00 | No | No | Current |