XL-3 Day Time
- Product NDC
- 84379-441
- 11-digit product format
- 843790441
- Labeler code
- 84379
- Product ID
- 84379-441_49635108-cf29-a6d3-e063-6394a90a9df0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Rnv LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XL-3 Day Time
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1113705 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84379-441-06 | XL-3 Day Time | 177 mL in 1 BOTTLE | LIQUID | 177 | | 3 |
| 84379-441-12 | XL-3 Day Time | 354 mL in 1 BOTTLE | LIQUID | 354 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84379-441 | XL-3 DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [RNV LLC] | 1 | Current NDC, 2 package rows | 20241212_2381ff41-4584-4b38-839f-f94e733f5bf2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84379-441-06 | 84379044106 | 177 mL in 1 BOTTLE (84379-441-06) | 177 ml | 2024-12-01 | No | No | Historical |
| 84379-441-12 | 84379044112 | 354 mL in 1 BOTTLE (84379-441-12) | 354 ml | 2024-12-01 | No | No | Historical |