What is NDC 36800-417?

36800-417 is the product NDC for Topcare Sinus and Cold D, Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Topcare Sinus and Cold D (Naproxen sodium, Pseudoephedrine HCl).

What is the active ingredient?

Naproxen sodium, Pseudoephedrine hydrochloride.

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Topcare Sinus and Cold D?

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.

Topcare Sinus and Cold D NDC 36800-417

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-417Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0417Add 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
36800-417-01	3680004170136800041701	20 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 14, 2013

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): Topcare Sinus and Cold D
Generic name (nonproprietary): naproxen sodium, pseudoephedrine hcl
Active ingredients: Naproxen sodium — 220 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076518
Marketing start: Aug 14, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 36800-417_7cdb2600-a9fa-4fe8-9161-4f051bb1243bSPL ID 7cdb2600-a9fa-4fe8-9161-4f051bb1243bSPL set ID 55c177ce-1729-4a9b-a5ae-2b6c96fbc27aRxCUI 1367426UNII 9TN87S3A3C, 6V9V2RYJ8N
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; alpha-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

N436800041701 followed by a unit qualifier and the quantity

Package 36800-0417-01. 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 Apr 17, 2025.

Indications (excerpt from the label)

Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-417

What is NDC 36800-417?: 36800-417 is the product NDC for Topcare Sinus and Cold D, Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topcare Sinus and Cold D (Naproxen sodium, Pseudoephedrine HCl).
What is the active ingredient?: Naproxen sodium, Pseudoephedrine hydrochloride.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topcare Sinus and Cold D?: 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 ANDA 076518

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

FDA NDC Directory listings under ANDA 076518
Product	Strength	Form · route	Labeler	Product NDC
Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochloride	Pseudoephedrine hydrochloride 120 mg/1; Naproxen sodium 220 mg/1	TabletOral	Bayer HealthCare LLC.	0280-6090
Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochloride	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	TabletOral	Bayer HealthCare LLC.	0280-6045
All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Walgreen Company	0363-0650
Leader All Day Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Cardinal Health 110, LLC. dba Leader	70000-0605
Mucinex DS 12HR COLD, FEVER and SINUSnaproxen sodium, pseudoephedrine hydrochloride	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Extended releaseOral	Reckitt Benckiser LLC	72854-223
Sinus and Cold Dnaproxen sodium, pseudoephedrine hcl	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	Meijer Distribution Inc	41250-417
Sinus and Cold Dnaproxen sodium, pseudoephedrine hydrochloride	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Film coated, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-339
Sudafed Sinus 12 Hour Pressure plus Painnaproxen sodium and pseudoephedrine hydrochloride	Naproxen sodium 220 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	Kenvue Brands LLC	50580-434

Topcare Sinus and Cold D (Naproxen sodium, pseudoephedrine hcl) NDC 36800-417