Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Relief (Acetaminophen) NDC 57344-170

Acetaminophen 500 mg/1 · Tablet, Coated · Oral · AAA Pharmaceutical, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)57344-170Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57344-0170Add 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
57344-170-02573440170021 BOTTLE, PLASTIC in 1 CARTON (57344-170-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 1, 2015

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)
Pain Relief
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
AAA Pharmaceutical, Inc.NDC labeler code 57344
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 57344-170_284f8938-9753-c321-e063-6294a90a4895SPL ID 284f8938-9753-c321-e063-6294a90a4895SPL set ID a891896d-c9fa-4448-915a-e6b531157d22RxCUI 198440UNII 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

N457344017002 followed by a unit qualifier and the quantity

Package 57344-0170-02. 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: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57344-170

What is NDC 57344-170?
57344-170 is the product NDC for Pain Relief (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by AAA Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Relief (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
AAA Pharmaceutical, Inc., NDC labeler code 57344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pain Relief?
62 other product NDCs are listed under this name. See all Pain Relief 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 Pain Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain ReliefacetaminophenAcetaminophen 325 mg/1TabletOralShield Pharmaceuticals Corp.83059-0160—
Pain Reliefmenthol sprayMenthol 76.6 mg/mLSprayTopicalOwell Naturals Brand, LLC83570-00383570-0003-02
Pain Reliefarnica montana, belladonna, gelsemium sempervirens, gnaphalium polycephalum, magnesia phosphorica, sanguinaria canadensis, salix albaArnica montana whole 6 [hp_X]/1 + 6 more ingredientsTabletOralNaturalCare70163-002270163-0022-01
pain reliefacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralHyVee Inc42507-81342507-0813-78
Pain ReliefmentholMenthol 10.5 g/100mLSprayTopicalTrifecta Pharmaceuticals USA, LLC.69396-17569396-0175-03
Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralHYVEE INC42507-10342507-0103-04
Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHYVEE INC42507-30342507-0303-03
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-40442507-0404-09
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-59242507-0592-03
Pain RelieflidocaineLidocaine .04 g/gPatchTopicalShanghai Chuangshi Medical Technology (Group) Co., Ltd.73557-18973557-0189-30

All 63 Pain Relief NDCs

Other NDCs under M 013

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

FDA NDC Directory listings under M 013
ProductStrengthForm · routeLabelerProduct NDC
365 whole foods market acetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralWhole Foods Market, INC.42681-0025
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-0657
AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0941
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1047
AcetaminophenAcetaminophen 325 mg/10.15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1314
AcetaminophenAcetaminophen 325 mg/10.15mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-1882
AcetaminophenAcetaminophen 650 mg/20.3mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1971
AcetaminophenAcetaminophen 325 mg/10.15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-2094
AcetaminophenAcetaminophen 650 mg/20.3mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-2823
AcetaminophenAcetaminophen 650 mg/20.3mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-3141
AcetaminophenAcetaminophen 500 mg/1TabletOralWALGREENS0363-9538
AcetaminophenAcetaminophen 500 mg/1TabletOralWALGREEN CO.0363-9595
AcetaminophenAcetaminophen 160 mg/1TabletOralWALGREEN CO.0363-9605
AcetaminophenAcetaminophen 500 mg/1TabletOralWALGREEN CO.0363-9798
AcetaminophenAcetaminophen 500 mg/1TabletOralWalgreens0363-9810
AcetaminophenAcetaminophen 500 mg/1TabletOralRugby Laboratories0536-1172
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralRugby Laboratories0536-1292
AcetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralRugby Laboratories0536-1413
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8608
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8609

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