Over-the-counter drug · ANDA

8 hr arthritis pain (Acetaminophen) NDC 51316-504

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-504Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0504Add 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 NDC11-digit (billing)PackageCopy
51316-504-795131605047951316050479400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51316-504-79)Marketed from Sep 29, 2025
51316-504-835131605048351316050483225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51316-504-83)Marketed from Sep 29, 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 arthritis pain
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
Marketing start
Listing expires
Identifiers
Product ID 51316-504_429c1da2-954d-412d-9065-bb67ebbdf3aaSPL ID 429c1da2-954d-412d-9065-bb67ebbdf3aaSPL set ID 68e5b8a7-17ca-4a29-9f0c-7350fcf65928RxCUI 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

N451316050479 followed by a unit qualifier and the quantity

Package 51316-0504-79. 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: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51316-504

What is NDC 51316-504?
51316-504 is the product NDC for 8 hr arthritis pain (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
8 hr arthritis pain (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, 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 arthritis pain?
1 other product NDC are listed under this name. See all 8 hr arthritis pain NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other 8 hr arthritis pain NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
8 HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.75907-43075907-0430-0175907-0430-40

Other NDCs under ANDA 075077

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

FDA NDC Directory listings under ANDA 075077
ProductStrengthForm · routeLabelerProduct NDC
DG Health 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-749
Topcare 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-369
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-221
Good Sense Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0044
equate 8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-345
Care One arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-544
Acetaminophen 650mgacetaminophenAcetaminophen 650 mg/1TabletOralForreal Pharmaceuticals, LLC81877-850
topcare 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-455
Leader 8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0736
acetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-150
arthritis pain relieveracetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0544
Equate Menstrual Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-420
dg health 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-828
Midol Long Lasting ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBayer HealthCare LLC.0280-8090
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2545
major acetaminophenacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-6883
Members Mark Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralSam's West Inc68196-611
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0544
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-544
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralASCLEMED USA INC.76420-590

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