Over-the-counter drug · ANDA

8HR Arthritis Pain (Acetaminophen) NDC 53942-200

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · Demoulas Super Markets, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)53942-200Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53942-0200Add 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
53942-200-0153942020001539420200011 BOTTLE, PLASTIC in 1 CARTON (53942-200-01) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Oct 26, 2026
53942-200-045394202000453942020004100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53942-200-04)Marketed from Oct 29, 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)
8HR Arthritis Pain
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Demoulas Super Markets, IncNDC labeler code 53942
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 53942-200_5efd2554-ba42-52e4-e063-6294a90aa90bSPL ID 5efd2554-ba42-52e4-e063-6294a90aa90bSPL set ID 5e848565-1d58-5ebc-e063-6394a90adbfcUNII 362O9ITL9DUPC 0049705831724

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

N453942020001 followed by a unit qualifier and the quantity

Package 53942-0200-01. 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 53942-200

What is NDC 53942-200?
53942-200 is the product NDC for 8HR Arthritis Pain (acetaminophen), Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by Demoulas Super Markets, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
8HR Arthritis Pain (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Demoulas Super Markets, Inc, NDC labeler code 53942. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 8HR Arthritis Pain?
1 other product NDC are listed under this name. See all 8HR 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 8HR Arthritis Pain NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-20081522-0200-03
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-20072036-0200-04

Other NDCs under ANDA 211544

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

FDA NDC Directory listings under ANDA 211544
ProductStrengthForm · routeLabelerProduct NDC
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-200
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBi-Mart37835-512
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC36800-632
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-201
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS PHARMACY iNC69842-297
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-200
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS PHARMACY INC69842-322
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-183
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-188
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-083
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-082
AcetaminophenAcetaminophen 650 mg/1TabletOralSAM'S WEST INC68196-935
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-160
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-1340
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWAL-MART STORES INC49035-181
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS0363-9992
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgacetaminophenAcetaminophen 650 mg/1TabletOralBENARD INDUSTRIES INC55959-179
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-892

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