NDC codes

FDA NDC Directory
Product NDC (as listed)49580-0685Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49580-0685Add 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
49580-0685-449580068504495800685041 BOTTLE, PLASTIC in 1 BOX (49580-0685-4) / 118 mL in 1 BOTTLE, PLASTICMarketed from Feb 28, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Dye Free Pain Reliever ChildrensSuffix: Childrens
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 160 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
P & L Development, LLCNDC labeler code 49580
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 49580-0685_f446b9fa-069b-48e1-8ae4-ec5ad945f67cSPL ID f446b9fa-069b-48e1-8ae4-ec5ad945f67cSPL set ID 45ddcaad-d416-4d7c-a84a-43548d5c5d3bRxCUI 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

N449580068504 followed by a unit qualifier and the quantity

Package 49580-0685-04. 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 temporarily 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 49580-0685

What is NDC 49580-0685?
49580-0685 is the product NDC for Dye Free Pain Reliever Childrens (acetaminophen), Acetaminophen 160 mg/5mL suspension, listed with the FDA by P & L Development, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dye Free Pain Reliever Childrens (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
P & L Development, LLC, NDC labeler code 49580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dye Free Pain Reliever Childrens?
1 other product NDC are listed under this name. See all Dye Free Pain Reliever Childrens 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 Dye Free Pain Reliever Childrens NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dye Free Pain Reliever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralSafeway, Inc.21130-28521130-0285-04

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
Headache Relief Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralTARGET Corporation11673-686
Aspirin Low Dose ChewableaspirinAspirin 81 mg/1Tablet, ChewableOralBetter Living Brands, LLC21130-397
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralKenvue Brands LLC50580-490
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-194
Acetaminophen Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralAurohealth LLC58602-748
AspirinAspirin 325 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-018
MejoralitoacetaminophenAcetaminophen 160 mg/5mLSuspensionOralOPMX Chula Vista69729-068
Ed ApapacetaminophenAcetaminophen 160 mg/5mLLiquidOralEDWARDS PHARMACEUTICALS, INC.0485-0057
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralAdvagen Pharma Limited72888-459
pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralKroger Company30142-590
equate pain relieveracetaminophenAcetaminophen 500 mg/1TabletOralWal-Mart Stores Inc49035-308
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-472
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralDISCOUNT DRUG MART53943-092
aspirinAspirin 81 mg/1Tablet, ChewableOralPublix Super Markets Inc56062-274
Acetaminophen Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralAurohealth LLC58602-745
AcetaminophenAcetaminophen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3959
Acetaminophen, Aspirin, CaffeineCaffeine 65 mg/1 + 2 more ingredientsTablet, Film coatedOralCVS Pharmacy, Inc.69842-541
AspirinAspirin 325 mg/1Tablet, CoatedOralFSA Store Inc.81522-018
AspirinAspirin 325 mg/1Tablet, Film coatedOralProficient Rx LP82804-167
Extra Strenght Headache Reliefacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralLil' Drug Store Products, Inc.29485-6538

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