XL-3 Night Time
- Product NDC
- 84379-444
- 11-digit product format
- 843790444
- Labeler code
- 84379
- Product ID
- 84379-444_49634dc2-a45b-f42b-e063-6294a90ade9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Rnv LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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 Night Time
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1043400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84379-444-06 | XL-3 Night Time | 177 mL in 1 BOTTLE | LIQUID | 177 | | 3 |
| 84379-444-12 | XL-3 Night 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 |
|---|
| 84379-444 | XL-3 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [RNV LLC] | 1 | Current NDC, 2 package rows | 20241212_03210929-331e-462d-b566-4e1865f52246.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 |
|---|
| 84379-444-06 | 84379044406 | 177 mL in 1 BOTTLE (84379-444-06) | 177 ml | 2024-12-01 | No | No | Historical |
| 84379-444-12 | 84379044412 | 354 mL in 1 BOTTLE (84379-444-12) | 354 ml | 2024-12-01 | No | No | Historical |