Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Relief Extra Strength (Acetaminophen) NDC 83324-078

Acetaminophen 500 mg/1 · Tablet, Coated · Oral · CHAIN DRUG MARKETING ASSOCIATION, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)83324-078Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83324-0078Add 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
83324-078-0183324007801833240078011 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 3, 2024
83324-078-058332400780583324007805500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05)Marketed from Apr 3, 2024
83324-078-158332400781583324007815150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15)Marketed from Apr 3, 2024
83324-078-2483324007824833240078241 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 3, 2024
83324-078-5083324007850833240078501 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 3, 2024

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
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.NDC labeler code 83324
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 83324-078_458b4f7d-8f0c-2559-e063-6294a90a663bSPL ID 458b4f7d-8f0c-2559-e063-6294a90a663bSPL set ID c57c10fc-f182-4153-8974-ef359a5f5ac1RxCUI 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

N483324007801 followed by a unit qualifier and the quantity

Package 83324-0078-01. 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: 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 83324-078

What is NDC 83324-078?
83324-078 is the product NDC for Pain Relief Extra Strength (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by CHAIN DRUG MARKETING ASSOCIATION, INC.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Relief Extra Strength (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
CHAIN DRUG MARKETING ASSOCIATION, INC., NDC labeler code 83324. 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.83324-08083324-0080-01
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
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-10453943-0104-0253943-0104-0453943-0104-06+1 more

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
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralATLANTIC BIOLOGICALS CORP.17856-3086
Childrens TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-614
Acetaminophen Regular strengthacetaminophenAcetaminophen 325 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-563
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralTOP CARE (Topco Associates LLC)36800-466
Acetaminophen 325 MgacetaminophenAcetaminophen 325 mg/1TabletOralProficient Rx LP71205-456
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHarris Teeter72036-170
Topcare AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralTopco Associates LLC36800-467
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-592
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-392
AcetaminophenAcetaminophen 500 mg/1TabletOralTrifecta Pharmaceuticals USA LLC69396-140
Goodnow Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralGobrands, Inc82501-0484
Tension Headache Pain Relieving Aidacetaminophen,caffeineAcetaminophen 500 mg/1; Caffeine 65 mg/1TabletOralWAL-MART STORES INC79903-373
Acetaminophen , Aspirin and CaffeineAspirin 250 mg/1 + 2 more ingredientsCapsuleOralSoftgel Healthcare Pvt Ltd35916-0709
AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0941
CareOne Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerican Sales Company41520-615
Childrens TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-612
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralAurex Laboratories Limited Liability Company71009-109
Acetaminophen PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHarris Teeter72036-171
Basic Care Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-130
good neighbor pharmacy aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralAmerisource Bergen24385-278

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