What is NDC 50580-208?

50580-208 is the product NDC for Motrin Dual Action With Tylenol, Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Motrin Dual Action With Tylenol (Acetaminophen and Ibuprofen).

Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Motrin Dual Action With Tylenol?

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.

Motrin Dual Action With Tylenol NDC 50580-208

NDC codes

FDA NDC Directory

Product NDC (as listed)50580-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50580-0208Add 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
50580-208-02	5058002080250580020802	1 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 20, 2023
50580-208-08	5058002080850580020808	1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 20, 2023
50580-208-12	5058002081250580020812	1 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 20, 2023
50580-208-16	5058002081650580020816	2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 1, 2024

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): Motrin Dual Action With Tylenol
Generic name (nonproprietary): acetaminophen and ibuprofen
Active ingredients: Ibuprofen — 125 mg/1Acetaminophen — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Kenvue Brands LLCNDC labeler code 50580
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214836
Marketing start: Mar 20, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71SPL ID 48d075d6-52f3-6fd7-e063-6394a90ada71SPL set ID f2ee9cf5-02b7-6612-e053-2995a90a90c4RxCUI 2387532UNII WK2XYI10QM, 362O9ITL9DUPC 0300450311207
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N450580020802 followed by a unit qualifier and the quantity

Package 50580-0208-02. 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 Feb 3, 2026.

Indications (excerpt from the label)

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-208

What is NDC 50580-208?: 50580-208 is the product NDC for Motrin Dual Action With Tylenol, Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Motrin Dual Action With Tylenol (Acetaminophen and Ibuprofen).
What is the active ingredient?: Ibuprofen, Acetaminophen.
Who is the labeler?: Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Motrin Dual Action With Tylenol?: 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 214836

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

FDA NDC Directory listings under ANDA 214836
Product	Strength	Form · route	Labeler	Product NDC
dual actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Rite Aid Corporation	11822-5777
dual pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-5220
dual pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Meijer, Inc.	79481-0503
equate dual pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	WALMART INC.	79903-243
foster and thrive dual actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services LLC	70677-1274
DG health dual pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Dolgencorp Inc	55910-441
dg health dual back pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Dolgencorp Inc	55910-508
equate dual back pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	WALMART INC.	79903-326
good sense dual actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-044
topcare dual actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Topco Associates LLC	76162-501
Topcare Dual Action Back Painacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Topco Associates LLC	76162-520
Basic Care Dual Actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-530
Dual Actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-542
Careone Dual Actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Retail Business Services, LLC	72476-231
Dual Actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	HyVee Inc	42507-540
Dual Back Pain Relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-6199
acetaminophen and ibuprofenacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Kroger Company	30142-720
dual actionacetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Publix Super Markets Inc	56062-530
Leader Dual Action Pain Relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	Cardinal Health 110, LLC. dba Leader	70000-0737
equate pain relieveracetaminophen, ibuprofen	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1	Tablet, Film coatedOral	WALMART INC.	79903-148

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Motrin Dual Action With Tylenol (Acetaminophen and ibuprofen) NDC 50580-208