Over-the-counter drug · OTC MONOGRAPH FINAL
Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength NDC 0363-0758
dextromethorphan hbr, doxylamine succinate · Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL · Solution · Oral · WALGREEN CO.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0758-04 | 0036307580400363075804 | 1 BOTTLE in 1 CARTON (0363-0758-04) / 118 mL in 1 BOTTLEMarketed from Sep 8, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength
- Generic name (nonproprietary)
- dextromethorphan hbr, doxylamine succinate
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/20mLDoxylamine succinate — 12.5 mg/20mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- WALGREEN CO.NDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0363-0758_385a1e0b-09c5-4f2d-8404-086020e5c891SPL ID 385a1e0b-09c5-4f2d-8404-086020e5c891SPL set ID 385a1e0b-09c5-4f2d-8404-086020e5c891RxCUI 1115329UNII 9D2RTI9KYH, V9BI9B5YI2
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N400363075804followed by a unit qualifier and the quantityPackage 00363-0758-04. 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 • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • controls the impulse to cough to help you sleep
Excerpt only. Read the full label for complete information.
About NDC 0363-0758
- What is NDC 0363-0758?
- 0363-0758 is the product NDC for Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength, Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL solution, listed with the FDA by WALGREEN CO.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength (Dextromethorphan HBr, Doxylamine succinate).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- WALGREEN CO., NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under part341
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 |
|---|---|---|---|---|
| Pseudo Time PEphenylephrine hchloride | Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC. | 49483-234 |
| Allergy Timechlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Time Cap Labs Inc | 49483-242 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Time-Cap Labs, Inc | 49483-329 |
| CVS Health Sinus Reliefoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-787 |
| Severe Cold Head Congestionacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-175 |
| CVS Health Childrens Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | CVS Pharmacy,Inc. | 59779-793 |
| CVS Health Four Actions Nasal Decongestantphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | CVS Pharmacy,Inc. | 59779-838 |
| Tussin CFdextromethorphan hbr guaifenesin phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/10mL + 2 more ingredients | SolutionOral | Strategic Sourcing Services | 70677-1187 |
| Tussinguaifenesin | Guaifenesin 200 mg/10mL | SolutionOral | Strategic Sourcing Services | 70677-1186 |
| Discount Drug Mart Value Vapor Steamcamphor (synthetic) | Camphor (Synthetic) .623 g/10mL | LiquidRespiratory (Inhalation) | Drug Mart | 53943-256 |
| Pressure Pain Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Chain Drug Marketing Association | 63868-747 |
| NightTime Cold and Fluacetaminophen,dextromethorphan,doxylamine | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Velocity Pharma | 76168-056 |
| Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Velocity Pharma LLC | 76168-121 |
| Nightime Sleep Aiddiphenhydramine | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Velocity Pharma | 76168-065 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-648 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-649 |
| Pi Yuan Chinnaphazoline hydrochloride | Naphazoline hydrochloride 1 mg/1 | Solution/ dropsNasal | International Nature Nutraceuticals | 51367-035 |
| Sugar Free Cherry Cough Dropsmenthol | Menthol 5.8 1/1 | LozengeOral | Army & Air Force Exchange Service | 55301-038 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
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