Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Relief Extra Strength (Acetaminophen 500 mg) NDC 69168-328

Acetaminophen 500 mg/1 · Tablet · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-328Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0328Add 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
69168-328-0169168032801100 TABLET in 1 CARTON (69168-328-01)Marketed from Dec 17, 2014
69168-328-1369168032813175 TABLET in 1 BOTTLE (69168-328-13)Marketed from Dec 17, 2014
69168-328-406916803284040 TABLET in 1 CARTON (69168-328-40)Marketed from Dec 17, 2014

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 Extra StrengthSuffix: Extra Strength
Generic name (nonproprietary)
acetaminophen 500 mg
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 69168-328_7ed5b51e-f50e-42cd-965e-2962d68ec75fSPL ID 7ed5b51e-f50e-42cd-965e-2962d68ec75fSPL set ID 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7RxCUI 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

N469168032801 followed by a unit qualifier and the quantity

Package 69168-0328-01. 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 temporary relief of minor aches and pains associated with ■ the common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ minor pain from arthritis ■ 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 69168-328

What is NDC 69168-328?
69168-328 is the product NDC for Pain Relief Extra Strength (acetaminophen 500 mg), Acetaminophen 500 mg/1 tablet, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Relief Extra Strength (Acetaminophen 500 mg).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Allegiant Health, NDC labeler code 69168. 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 Extra Strength?
31 other product NDCs are listed under this name. See all Pain Relief Extra Strength 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 Extra Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-07983324-0079-50
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralChain Drug Marketing Association83324-08183324-0081-0183324-0081-1083324-0081-60
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-07883324-0078-0183324-0078-0583324-0078-15+2 more
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-08083324-0080-01
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralSTRATEGIC SOURCING SERVICES LLC70677-112070677-1120-0170677-1120-02
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralSTRATEGIC SOURCING SERVICES LLC70677-112470677-1124-01
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-10468998-0104-0468998-0104-06
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-19868998-0198-02
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-39268998-0392-01
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralDISCOUNT DRUG MART53943-10353943-0103-0253943-0103-04

All 32 Pain Relief Extra Strength 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

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in