Over-the-counter drug · OTC MONOGRAPH DRUG

TYLENOL Regular Strength (Acetaminophen) NDC 50580-475

Acetaminophen 325 mg/1 · Tablet, Film coated · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-475Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0475Add 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
50580-475-1050580047510505800475101 BOTTLE in 1 CARTON (50580-475-10) / 1000 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 30, 2025
50580-475-11505800475115058004751110 BLISTER PACK in 1 CARTON (50580-475-11) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 30, 2025
50580-475-5050580047550505800475501 BOTTLE in 1 CARTON (50580-475-50) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 30, 2025

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)
TYLENOL Regular StrengthSuffix: Regular Strength
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 325 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 50580-475_398d8996-b523-a3cd-e063-6394a90ac2c8SPL ID 398d8996-b523-a3cd-e063-6394a90ac2c8SPL set ID 398d8996-b522-a3cd-e063-6394a90ac2c8RxCUI 209387, 313782UNII 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

N450580047510 followed by a unit qualifier and the quantity

Package 50580-0475-10. 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: -headache -muscular aches -backache -minor pain of arthritis -the common cold -toothache -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 50580-475

What is NDC 50580-475?
50580-475 is the product NDC for TYLENOL Regular Strength (acetaminophen), Acetaminophen 325 mg/1 tablet, film coated, listed with the FDA by Kenvue Brands LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TYLENOL Regular Strength (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TYLENOL Regular Strength?
3 other product NDCs are listed under this name. See all TYLENOL Regular 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 TYLENOL Regular Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TYLENOL Regular StrengthacetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-45850580-0458-1150580-0458-50
TYLENOL Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralKenvue Brands LLC50580-49550580-0495-01
TYLENOL Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralKenvue Brands LLC50580-49650580-0496-6050580-0496-98

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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