What is NDC 48201-001?

48201-001 is the product NDC for Sanaflu Xtra, Dextromethorphan hydrobromide 10 mg/1 + 3 more ingredients capsule, gelatin coated, listed with the FDA by GRANDALL DISTRIBUTING, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sanaflu Xtra (Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride).

What is the active ingredient?

Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Acetaminophen, Chlorpheniramine maleate.

GRANDALL DISTRIBUTING, LLC, NDC labeler code 48201. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sanaflu Xtra?

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.

Sanaflu Xtra NDC 48201-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)48201-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width48201-0001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
48201-001-12	4820100011248201000112	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, LLCNDC labeler code 48201
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Apr 30, 2015
Listing expires: Dec 31, 2026
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

N448201000112 followed by a unit qualifier and the quantity

Package 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 Oct 28, 2025.

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.

Full label on DailyMed (opens in a new tab)

About NDC 48201-001

What is NDC 48201-001?: 48201-001 is the product NDC for Sanaflu Xtra, Dextromethorphan hydrobromide 10 mg/1 + 3 more ingredients capsule, gelatin coated, listed with the FDA by GRANDALL DISTRIBUTING, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sanaflu Xtra (Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride).
What is the active ingredient?: Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Acetaminophen, Chlorpheniramine maleate.
Who is the labeler?: GRANDALL DISTRIBUTING, LLC, NDC labeler code 48201. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sanaflu Xtra?: 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 M 013

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 013
Product	Strength	Form · route	Labeler	Product NDC
Headache Relief Extra Strengthacetaminophen, aspirin, caffeine	Acetaminophen 250 mg/1 + 2 more ingredients	TabletOral	TARGET Corporation	11673-686
Aspirin Low Dose Chewableaspirin	Aspirin 81 mg/1	Tablet, ChewableOral	Better Living Brands, LLC	21130-397
TYLENOL Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Kenvue Brands LLC	50580-490
Medlineacetaminophen	Acetaminophen 325 mg/1	TabletOral	Medline Industries, LP	53329-194
Acetaminophen Regular Strengthacetaminophen	Acetaminophen 325 mg/1	TabletOral	Aurohealth LLC	58602-748
Aspirin	Aspirin 325 mg/1	Tablet, CoatedOral	Marc Glassman, Inc.	68998-018
Mejoralitoacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	OPMX Chula Vista	69729-068
Ed Apapacetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	EDWARDS PHARMACEUTICALS, INC.	0485-0057
Childrens Acetaminophenacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Advagen Pharma Limited	72888-459
pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Kroger Company	30142-590
equate pain relieveracetaminophen	Acetaminophen 500 mg/1	TabletOral	Wal-Mart Stores Inc	49035-308
Tylenol Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Kenvue Brands LLC	50580-472
Pain Reliefacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	DISCOUNT DRUG MART	53943-092
aspirin	Aspirin 81 mg/1	Tablet, ChewableOral	Publix Super Markets Inc	56062-274
Acetaminophen Extra Strengthacetaminophen	Acetaminophen 500 mg/1	TabletOral	Aurohealth LLC	58602-745
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3959
Acetaminophen, Aspirin, Caffeine	Caffeine 65 mg/1 + 2 more ingredients	Tablet, Film coatedOral	CVS Pharmacy, Inc.	69842-541
Aspirin	Aspirin 325 mg/1	Tablet, CoatedOral	FSA Store Inc.	81522-018
Aspirin	Aspirin 325 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-167
Extra Strenght Headache Reliefacetaminophen, aspirin, caffeine	Acetaminophen 250 mg/1 + 2 more ingredients	TabletOral	Lil' Drug Store Products, Inc.	29485-6538

Showing 20 of 40.