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
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYNCOF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| GUAIFENESIN | 400 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113368 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-400-01 | ML - Milliliter | 52083-400 | f9c657ae-aa72-410c-a3a1-3a2b10c2a7b0 | 1 | 2017-04-05 |
| 52083-400-04 | ML - Milliliter | 52083-400 | 601296d5-d808-4845-a5be-af602f497ea0 | 1 | 2012-07-24 |
| 52083-400-16 | ML - Milliliter | 52083-400 | 845a08ee-89d4-4d5a-9ff6-03c1e02384b8 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucus Relief Immediate Release | GUAIFENESIN | Allegiant Health | 221d64a2-b8c7-435a-aae4-fb58fd38108f | 2019-03-26 | Warnings | M012 |
| Sleep Tabs For Nighttime use | DIPHENHYDRAMINE HCL TABLETS | Allegiant Health | 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d | 2018-12-26 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Allegiant Health | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 2018-12-26 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | dbbc535f-515a-4d9b-b799-34e60f5230bb | 2018-12-21 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Allegiant Health | c2823bad-540f-4662-8dcc-58e9f0d94efb | 2018-11-07 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength Non-Drowsy | PHENYLEPHRINE 10 MG | Allegiant Health | 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 | 2018-11-07 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a58bfb14-28f9-4425-a5a5-aaff4847c979 | 2018-03-14 | Warnings | M012 |
| Chlorpheniramine maleate 4mg | CHLORPHENIRAMINE MALEATE 4MG | Athlete's Needs, Inc. | 4d974959-25fc-4707-9b72-9afbf47b76f1 | 2017-11-14 | Warnings | M012 |
| Cold Medicine | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Selder, S.A. de C.V. | d2762d9c-e7e7-42b2-a26a-14b2aa0307cb | 2017-01-25 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Marc Glassman, Inc. | 2051247f-ce64-4cf5-b449-9ca14c43ab86 | 2016-12-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113368 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution | PSN | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 6 |
| 1113368 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution | SCD | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 6 |
| 1113368 | dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution | SY | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 6 |
| 1113368 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup | SY | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 6 |
Packages#
| 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 |