Over-the-counter drug · OTC MONOGRAPH DRUG
Tusnel-DM Pediatric NDC 54859-606
dextromethorphan hbr, guaifenesin, phenylephrine hcl · Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients · Solution/ drops · Oral · LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54859-606-01 | 5485906060154859060601 | 30 mL in 1 BOTTLE, DROPPER (54859-606-01)Marketed from Aug 1, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tusnel-DM Pediatric
- Generic name (nonproprietary)
- dextromethorphan hbr, guaifenesin, phenylephrine hcl
- Active ingredients
- Dextromethorphan hydrobromide — 2.5 mg/mLGuaifenesin — 25 mg/mLPhenylephrine hydrochloride — 1.25 mg/mL
- Dosage form
- Solution/ drops
- Route
- Oral
- Labeler
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONNDC labeler code 54859
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 54859-606_47463023-1b8d-729b-e063-6394a90a8dceSPL ID 47463023-1b8d-729b-e063-6394a90a8dceSPL set ID 64e36b02-b5be-4d20-8818-cb5b23596671RxCUI 2268062UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454859060601followed by a unit qualifier and the quantityPackage 54859-0606-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Temporary relief of cough due to minor throat and bronchial irritation Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Excerpt only. Read the full label for complete information.
About NDC 54859-606
- What is NDC 54859-606?
- 54859-606 is the product NDC for Tusnel-DM Pediatric, Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients solution/ drops, listed with the FDA by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tusnel-DM Pediatric (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION, NDC labeler code 54859. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tusnel-DM Pediatric?
- 1 other product NDC are listed under this name. See all Tusnel-DM Pediatric NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tusnel-DM Pediatric products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tusnel DM Pediatricdextromethorphan, guiafenesin, pseudoephedrine hcl | Guaifenesin 25 mg/mL + 2 more ingredients | Solution/ dropsOral | Llorens Pharmaceutical International Division | 54859-603 | 54859-0603-02 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 |
| Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | HyVee Inc | 42507-598 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | H E B | 37808-932 |
| Medi First Plus Cherry Cough Dropsmenthol | Menthol 7.6 mg/1 | LozengeOral | Unifirst First Aid Corporation | 47682-915 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-057 |
| SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin | Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 | TabletOral | KRAMER LABORATORIES | 55505-231 |
| Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Dolgencorp Inc | 55910-753 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SolutionNasal | Reckitt Benckiser LLC | 63824-120 |
| Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | Procter & Gamble Manufacturing GmbH | 64336-002 |
| Walgreens Honey Lemon Cough Dropsmenthol | Menthol 7.5 mg/1 | LozengeOral | Walgreens | 0363-9959 |
| Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl | Acetaminophen 500 mg/20mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-787 |
| Guaifenesin | Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9616 |
| Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-175 |
| DG Health Cough Drops Cherry Flavormenthol | Menthol 5.8 mg/1 | LozengeTopical | Dollar General Corporation | 75712-005 |
| Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-019 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6985 |
| severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Rite Aid Corporation | 11822-3120 |
| Supress Dx Pediatric Dropsdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Dextromethorphan hydrobromide 5 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-051 |
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