Niaflu
- Product NDC
- 55758-507
- 11-digit product format
- 557580507
- Labeler code
- 55758
- Product ID
- 55758-507_4628aefb-6ec6-af1b-e063-6294a90a1f86
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-10
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 400 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Niaflu
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1661740 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-507-01 | Niaflu | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | | 2 |
| 55758-507-01 | Niaflu | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55758-507-01 | 55758050701 | 1 BLISTER PACK in 1 CARTON (55758-507-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2025-07-10 | No | No | Historical |