Over-the-counter drug · OTC MONOGRAPH DRUG

Acetaminophen NDC 0121-0941

Acetaminophen 160 mg/5mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma

NDC codes

FDA NDC Directory
Product NDC (as listed)0121-0941Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-0941Add 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
0121-0941-00001210941000012109410010 TRAY in 1 CASE (0121-0941-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0941-05)Marketed from Sep 3, 2021
0121-0941-9400121094194001210941943 TRAY in 1 CASE (0121-0941-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0941-05)Marketed from Sep 3, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Acetaminophen
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 160 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 0121-0941_bbd6f65a-a6ec-4c17-935c-ed743c45e2c8SPL ID bbd6f65a-a6ec-4c17-935c-ed743c45e2c8SPL set ID caf5daea-409e-5dd2-e053-2995a90acb12RxCUI 307668UNII 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

N400121094100 followed by a unit qualifier and the quantity

Package 00121-0941-00. 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: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0941

What is NDC 0121-0941?
0121-0941 is the product NDC for Acetaminophen, Acetaminophen 160 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acetaminophen.
What is the active ingredient?
Acetaminophen.
Who is the labeler?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen?
227 other product NDCs are listed under this name. See all Acetaminophen 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 Acetaminophen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
acetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-15072288-0150-79
AcetaminophenAcetaminophen 10 mg/mLInjection, SolutionIntravenousSomerset Therapeutics, LLC70069-87170069-0871-10
AcetaminophenAcetaminophen 500 mg/1TabletOralWalgreens0363-981000363-9810-1000363-9810-2500363-9810-50+1 more
AcetaminophenAcetaminophen 500 mg/1TabletOralPUBLIX SUPERMARKETS, INC41415-17541415-0175-0541415-0175-10
AcetaminophenAcetaminophen 500 mg/1TabletOralFamily Dollar, Inc.55319-75155319-0751-24
AcetaminophenAcetaminophen 500 mg/1TabletOralMeijer Distribution Inc79481-078079481-0780-0179481-0780-0279481-0780-04
AcetaminophenAcetaminophen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-413268788-4132-0168788-4132-0268788-4132-03+1 more
acetaminophenAcetaminophen 500 mg/1TabletOralUnit Dose Solutions, Inc.87441-00887441-0008-01
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralAcetris Pharma Holdings, LLC52343-55552343-0555-12
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-89262207-0892-4962207-0892-51

All 228 Acetaminophen 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
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
TYLENOL Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralKenvue Brands LLC50580-495

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