Over-the-counter drug · ANDA
8 Hr Muscle Aches And Pain (Acetaminophen) NDC 51316-354
Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-354-42 | 5131603544251316035442 | 1 BOTTLE in 1 CARTON (51316-354-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jun 25, 2025 |
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)
- 8 Hr Muscle Aches And Pain
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- CVS PharmacyNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215486
- Marketing start
- Listing expires
- Identifiers
- Product ID 51316-354_33d1710e-b90e-c820-e063-6394a90aaf15SPL ID 33d1710e-b90e-c820-e063-6394a90aaf15SPL set ID 2eb6fc42-6ba4-8f58-e063-6294a90ac6a0RxCUI 1148399UNII 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
N451316035442followed by a unit qualifier and the quantityPackage 51316-0354-42. 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: - muscular aches - backache - minor pain of arthritis - toothache - premenstrual and menstrual cramps - headache - the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 51316-354
- What is NDC 51316-354?
- 51316-354 is the product NDC for 8 Hr Muscle Aches And Pain (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by CVS Pharmacy. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 8 Hr Muscle Aches And Pain (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- CVS Pharmacy, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 8 Hr Muscle Aches And Pain?
- 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 215486
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 |
|---|---|---|---|---|
| 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-704 |
| Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | KROGER COMPANY | 41226-699 |
| 8HR Arthritis Pain Reliefacetaminophen 650mg | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 51316-969 |
| 8HR Muscle Aches and Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0734 |
| Acetaminophenacetaminophen tablet extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | TIME CAP LABORATORIES, INC. | 49483-699 |
| Muscle Aches and Pains Acetaminophen extended releaseacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | TIME CAP LABORATORIES, INC. | 49483-704 |
| Arthritis Pain Relieveracetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | WALGREENS | 0363-9781 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | SAM'S WEST INC | 68196-034 |
| Acetaminophen Extended-Release Tablets, 650 mgacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | MARKSANS PHARMA LIMITED | 25000-071 |
| 8 hr Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | DOLGENCORP, INC. | 55910-892 |
| Acetaminophen Extended-Release Tablets, 650 mgacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | MARKSANS PHARMA LIMITED | 25000-108 |
| 8 hr Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | DOLGENCORP, INC. | 55910-895 |
| 8HR Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0733 |
| Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | BETTER LIVING BRANDS, LLC | 21130-097 |
| 8HR Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | TARGET CORPORATION | 11673-928 |
| Acetaminophenacetaminophen tablet extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9746 |
| Acetaminophenacetaminophen tablet extended release | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-914 |
| 8hr arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Major Pharmaceuticals | 0904-7561 |
| Arthritis Pain Acetaminophenacetaminophen | Acetaminophen 650 mg/1 | TabletOral | TARGET CORPORATION | 11673-673 |