TUSICOF
- Product NDC
- 52083-239
- 11-digit product format
- 520830239
- Labeler code
- 52083
- Product ID
- 52083-239_e954ebb2-df25-40bf-b068-8ac861d6677b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan, guaifenesin, and phenylephrine
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-08-17
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 20; 400; 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- 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
- TUSICOF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| GUAIFENESIN | 400 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1091331 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e966b75c-4bb4-4216-8247-baada8f5d759 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-239-01 | TUSICOF | 30 mL in 1 BOTTLE | SYRUP | 30 | 7 | |
| 52083-239-04 | TUSICOF | 120 mL in 1 BOTTLE | SYRUP | 120 | 7 | |
| 52083-239-16 | TUSICOF | 474 mL in 1 BOTTLE | SYRUP | 474 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-239-04 | ML - Milliliter | 52083-239 | b715ea09-053c-42b6-ba32-08b9368055d4 | 1 | 2012-07-24 |
| 52083-239-16 | ML - Milliliter | 52083-239 | 38e2d9a5-bfde-4e35-90a8-1c6f4175a090 | 1 | 2013-02-13 |
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 |
|---|---|---|---|---|---|---|
| Severe Cold and Flu Daytime Honey | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0fa3d-d6b2-272a-e063-6394a90a1205 | 2024-05-08 | Warnings | M012 |
| Childrens Plus Multi Symptom Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | dd967cfb-96b4-4cdc-82e2-a4838001c9e3 | 2024-05-08 | Warnings | M012 |
| Childrens Wal Tap Elixer Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Walgreens | 3f438f28-d1ad-44da-a573-f1b0824b051c | 2024-05-08 | Warnings | M012 |
| Cough Cold and Sore Throat Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 400a0998-e276-4c8d-9b41-145b1b405fff | 2024-05-08 | Warnings | M012 |
| Mucus Congestion and Cough Relief Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI | Walgreens | 19cd2409-d56b-4319-833c-eacc7dc498c1 | 2024-05-08 | Warnings | M012 |
| Severe Cold and Flu Nighttime Honey | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b12f0e-dba7-fd71-e063-6294a90a42c1 | 2024-05-06 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE | Kroger | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2024-05-06 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger | 1014da86-3a0e-136f-e063-6294a90ac931 | 2024-05-04 | Warnings | M012 |
| Robitussin Honey Maximum Strength Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | eaa10aed-5b1e-48bf-bc05-7a5638851daf | 2024-05-03 | Warnings | M012 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | e35cb719-9e7d-4b2b-81a4-29e147dd74fa | 2024-05-03 | Warnings | M012 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | 09e20842-2b75-43b9-ae5f-3515b35e655b | 2024-05-03 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | f958d8ba-ede9-4b1a-8317-2404b68a9129 | 2024-05-03 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab57d70-ba54-416f-9f14-b64d2238ea16 | 2024-05-03 | Warnings | M012 |
| Tussin CF Non Drowsy Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | 8ee27600-4f8e-406a-8ea3-eade691448f6 | 2024-05-03 | Warnings | M012 |
| SanaTos Children Cough and Congestion Cherry | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Pharmadel LLC | 60437d86-9e13-8d8a-e053-2991aa0a2317 | 2024-05-02 | Warnings | M012 |
| Robitussin Honey Maximum Strength Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 0b41da13-18a1-4987-ae43-1319bfa27484 | 2024-05-01 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a | 2024-05-01 | Warnings | M012 |
| Night Time Cold and Flu Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | dbfb8971-a122-4a97-a665-e3f0d494876e | 2024-05-01 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | c08b150c-d821-466c-8521-f77535d6af1e | 2024-04-30 | Warnings | M012 |
| childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreen Company | 7848bb09-2af8-47f6-b32d-96635a750a55 | 2024-04-29 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091331 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | e966b75c-4bb4-4216-8247-baada8f5d759 | 7 |
| 1091331 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | e966b75c-4bb4-4216-8247-baada8f5d759 | 7 |
| 1091331 | dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution | SY | e966b75c-4bb4-4216-8247-baada8f5d759 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-239-01 | 52083023901 | 30 mL in 1 BOTTLE (52083-239-01) | 30 ml | 2010-08-17 | 0000-00-00 | No | No | Current |
| 52083-239-04 | 52083023904 | 120 mL in 1 BOTTLE (52083-239-04) | 120 ml | 2010-08-17 | 0000-00-00 | No | No | Current |
| 52083-239-16 | 52083023916 | 474 mL in 1 BOTTLE (52083-239-16) | 474 ml | 2012-10-08 | 0000-00-00 | No | No | Current |