Over-the-counter drug · OTC MONOGRAPH DRUG
Sanaflu Xtra NDC 48201-001
Dextromethorphan hydrobromide 10 mg/1 + 3 more ingredients · Capsule, Gelatin coated · Oral · GRANDALL DISTRIBUTING, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48201-001-12 | 48201000112 | 12 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12)Marketed from Apr 30, 2015 |
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)
- Sanaflu Xtra
- Generic name (nonproprietary)
- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
- Active ingredients
- Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1Acetaminophen — 250 mg/1Chlorpheniramine maleate — 2 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- GRANDALL DISTRIBUTING, LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 48201-001_42404180-fa1a-fcf6-e063-6394a90a281fSPL ID 42404180-fa1a-fcf6-e063-6394a90a281fSPL set ID 4af8a566-5251-4d46-8692-87a3a0748334RxCUI 1193292UNII 9D2RTI9KYH, 04JA59TNSJ, 362O9ITL9D, V1Q0O9OJ9ZUPC 0348201018142
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N448201000112followed by a unit qualifier and the quantityPackage 48201-0001-12. 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 relives minor aches and pains headache runny nose sneezing nasal congestion itchy, watery eyes due to hay fever or other upper respiratory allergies itching of the nose or throat cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants Temperarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under M 013
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 |
|---|---|---|---|---|
| equate pain relieveracetaminophen | Acetaminophen 325 mg/1 | TabletOral | WALMART INC. | 79903-299 |
| Unishield Aspirinaspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | Unishield | 49314-1163 |
| dg health aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Dolgencorp, LLC | 55910-467 |
| Nite-Time COLD/FLU ORIGINALacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Salado Sales, Inc. | 57243-501 |
| Aspirina Cafeinaaspirin,caffeine | Caffeine 32.5 mg/1; Aspirin 500 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0162 |
| Aspirin Low Dose Safety Coatedaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | Care One (Retail Business Services, LLC.) | 72476-263 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALMART INC | 79903-296 |
| Dolex Children Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Pharmadel LLC | 55758-026 |
| Acetaminophen PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | WinCo Foods, LLC | 67091-137 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Walgreen Company | 0363-0218 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Meijer Distribution Inc | 79481-0780 |
| Children Acetaminophen Oral Solutionacetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | MAJOR PHARMACEUTICALS | 0904-7014 |
| Headache Relief Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | Safeway, Inc. | 21130-586 |
| Back and Body Extra Strengthaspirin, caffeine | Aspirin 500 mg/1; Caffeine 32.5 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-143 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 960 mg/30mL | SuspensionOral | Kenvue Brands LLC | 50580-187 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Prostat First Aid | 58228-0061 |
| Aspirin 81mgaspirin enteric coated tablets 81mg | Aspirin 81 mg/1 | TabletOral | VITANE PHARMACEUTICALS, INC | 60577-807 |
| Acetaminophen PMacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-056 |
| Childrens Pain and Fever, Grape flavoracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreen Company | 0363-0323 |
| Amazon Basics Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Amazon.com Services LLC | 72288-008 |
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