What is NDC 76162-501?

76162-501 is the product NDC for topcare dual action, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

topcare dual action (Acetaminophen, Ibuprofen).

Topco Associates LLC, NDC labeler code 76162. 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 dual action?

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 dual action NDC 76162-501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76162-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76162-0501Add 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
76162-501-16	7616205011676162050116	1 BOTTLE in 1 CARTON (76162-501-16) / 144 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 6, 2023
76162-501-23	7616205012376162050123	1 BOTTLE in 1 CARTON (76162-501-23) / 72 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 6, 2023
76162-501-68	7616205016876162050168	1 BOTTLE in 1 CARTON (76162-501-68) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 6, 2023

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 dual action
Generic name (nonproprietary): acetaminophen, ibuprofen
Active ingredients: Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 76162
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214836
Marketing start: Mar 6, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 76162-501_fa1893d9-493a-4bf7-920e-b96d9f84dc93SPL ID fa1893d9-493a-4bf7-920e-b96d9f84dc93SPL set ID dddc04c4-d500-4d42-8406-89f27a9ad651RxCUI 2387532UNII 362O9ITL9D, WK2XYI10QM
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

N476162050116 followed by a unit qualifier and the quantity

Package 76162-0501-16. 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 Jun 4, 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 76162-501

What is NDC 76162-501?: 76162-501 is the product NDC for topcare dual action, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, film coated, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: topcare dual action (Acetaminophen, Ibuprofen).
What is the active ingredient?: Acetaminophen, Ibuprofen.
Who is the labeler?: Topco Associates LLC, NDC labeler code 76162. 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 dual action?: 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
Motrin Dual Action With Tylenolacetaminophen and ibuprofen	Ibuprofen 125 mg/1; Acetaminophen 250 mg/1	Tablet, Film coatedOral	Kenvue Brands LLC	50580-208
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 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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topcare dual action (Acetaminophen, ibuprofen) NDC 76162-501