Over-the-counter drug · OTC MONOGRAPH DRUG

Tylenol Extra Strength (Acetaminophen) NDC 73097-012

Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Savings Distributors LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)73097-012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73097-0012Add 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
73097-012-0273097001202730970012021 POUCH in 1 CARTON (73097-012-02) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Jul 22, 2019
73097-012-40730970012407309700124020 POUCH in 1 CARTON (73097-012-40) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Jul 22, 2019
73097-012-50730970012507309700125025 POUCH in 1 BOX (73097-012-50) / 2 TABLET, FILM COATED in 1 POUCHMarketed from Jul 22, 2019

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 Extra Strength
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Savings Distributors LLCNDC labeler code 73097
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 73097-012_518f6c13-a0c6-5f9c-e063-6294a90a74d5SPL ID 518f6c13-a0c6-5f9c-e063-6294a90a74d5SPL set ID 8ed90757-833e-f4d9-e053-2995a90a29dbRxCUI 198440, 209459UNII 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

N473097001202 followed by a unit qualifier and the quantity

Package 73097-0012-02. 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 menstual cramps ■ temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73097-012

What is NDC 73097-012?
73097-012 is the product NDC for Tylenol Extra Strength (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Savings Distributors LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tylenol Extra Strength (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Savings Distributors LLC, NDC labeler code 73097. 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 Extra Strength?
23 other product NDCs are listed under this name. See all Tylenol 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 Tylenol Extra Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TYLENOL Extra StrengthacetaminophenAcetaminophen 960 mg/30mLSuspensionOralKenvue Brands LLC50580-18750580-0187-08
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-46950580-0469-1850580-0469-4050580-0469-75
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-10850580-0108-25
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-49150580-0491-0150580-0491-1050580-0491-70
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-47250580-0472-0150580-0472-0250580-0472-03+1 more
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralR J General Corporation70264-02770264-0027-01
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralKenvue Brands LLC50580-49050580-0490-0250580-0490-1050580-0490-20+4 more
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-45750580-0457-1050580-0457-1150580-0457-70
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/.95gPowderOralKenvue Brands LLC50580-20950580-0209-0250580-0209-04
Tylenol Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-546950090-5469-00

All 24 Tylenol 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
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralGrocery Outlet, Inc.85828-922
Pain Relief Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC83324-076
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
good neighbor pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-210
AspirinAspirin 81 mg/1Tablet, Delayed releaseOralGOODSENSE50804-880
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralMorning Star OTC53209-1002
AcetaminophenAcetaminophen 500 mg/1TabletOralCardinal Health 107, LLC55154-7897
Headache Formula Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-334
childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreen Company0363-1239
Tylenol PMacetaminophen, diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralSavings Distributors LLC73097-013
Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonateAnhydrous citric acid 1000 mg/1 + 2 more ingredientsTablet, EffervescentOralBayer HealthCare LLC.0280-4000
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1260
basic care infants pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-946
AcetaminophenAcetaminophen 500 mg/1TabletOralSportpharm LLC85766-223
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralUnited Natural Foods, Inc. dba UNFI41163-421
Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralChain Drug Consortium, LLC68016-154
Tension Headache ReliefAcetaminophen 500 mg/1; Caffeine 65 mg/1Capsule, CoatedOralAllegiant Health69168-001
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralProficient Rx LP71205-263
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-075

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