Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen NDC 52343-555
Acetaminophen 160 mg/5mL · Solution · Oral · Acetris Pharma Holdings, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52343-555-12 | 52343055512 | 118 mL in 1 BOTTLE, PLASTIC (52343-555-12)Marketed from May 13, 2026 |
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)
- Acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 160 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Acetris Pharma Holdings, LLCNDC labeler code 52343
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M013.50
- Marketing start
- Listing expires
- Identifiers
- Product ID 52343-555_68776ec5-dc83-4edb-b117-3326c2d999aaSPL ID 68776ec5-dc83-4edb-b117-3326c2d999aaSPL set ID dacbe2eb-f412-4629-a8ff-237c7fd10ab6RxCUI 307675UNII 362O9ITL9D
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
N452343055512followed by a unit qualifier and the quantityPackage 52343-0555-12. 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 relieves minor aches and pains due to: headache muscular aches backache arthritis the common cold toothache menstrual cramps reduces fever
Excerpt only. Read the full label for complete information.
About NDC 52343-555
- What is NDC 52343-555?
- 52343-555 is the product NDC for Acetaminophen, Acetaminophen 160 mg/5mL solution, listed with the FDA by Acetris Pharma Holdings, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen.
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Acetris Pharma Holdings, LLC, NDC labeler code 52343. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen?
- 232 other product NDCs are listed under this name. See all Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Amazon.com Services LLC | 72288-150 | 72288-0150-79 |
| Acetaminophen | Acetaminophen 10 mg/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-871 | 70069-0871-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Walgreens | 0363-9810 | 00363-9810-1000363-9810-2500363-9810-50+1 more |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-175 | 41415-0175-0541415-0175-10 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar, Inc. | 55319-751 | 55319-0751-24 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Meijer Distribution Inc | 79481-0780 | 79481-0780-0179481-0780-0279481-0780-04 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4132 | 68788-4132-0168788-4132-0268788-4132-03+1 more |
| acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-008 | 87441-0008-01 |
| Acetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Granules India Limited | 62207-892 | 62207-0892-4962207-0892-51 |
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-170 | 85828-0170-01 |
Other NDCs under M013.50
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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 160 mg/5mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-304 |
| Aspirin 81aspirin | Aspirin 81 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-302 |