ZYNCOF
- Product NDC
- 52083-400
- 11-digit product format
- 520830400
- Labeler code
- 52083
- Product ID
- 52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr and Guaifenesin
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-06-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 400 mg/5mL; mg/5mL
- 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
- ZYNCOF
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| GUAIFENESIN | 400 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1113368 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52083-400-01 | ZYNCOF | 30 mL in 1 BOTTLE, PLASTIC | SYRUP | 30 | | 6 |
| 52083-400-04 | ZYNCOF | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | | 6 |
| 52083-400-16 | ZYNCOF | 474 mL in 1 BOTTLE, PLASTIC | SYRUP | 474 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52083-400 | ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241012_cffd6d5f-0cb2-4d38-bdb0-6a21120418cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52083-400-01 | 52083040001 | 30 mL in 1 BOTTLE, PLASTIC (52083-400-01) | 30 ml | 2011-06-01 | 0000-00-00 | No | No | Current |
| 52083-400-04 | 52083040004 | 120 mL in 1 BOTTLE, PLASTIC (52083-400-04) | 120 ml | 2011-06-01 | 0000-00-00 | No | No | Current |
| 52083-400-16 | 52083040016 | 474 mL in 1 BOTTLE, PLASTIC (52083-400-16) | 474 ml | 2013-01-23 | 0000-00-00 | No | No | Current |