Over-the-counter drug · OTC MONOGRAPH DRUG

PANADOL Extra Strength (acetaminophen) NDC 0135-0609

Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Haleon US Holdings LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0135-0609Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00135-0609Add 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
0135-0609-01001350609011 BOTTLE in 1 CARTON (0135-0609-01) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 15, 2017
0135-0609-02001350609021 BOTTLE in 1 CARTON (0135-0609-02) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 15, 2017
0135-0609-03001350609031 BOTTLE in 1 CARTON (0135-0609-03) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 15, 2017
0135-0609-040013506090450 PACKET in 1 CARTON (0135-0609-04) / 2 TABLET, FILM COATED in 1 PACKET (0135-0609-05)Marketed from Mar 15, 2017

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)
PANADOL Extra StrengthSuffix: Extra Strength
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 0135-0609_10c10ae1-2b66-f708-e063-6394a90a0fcaSPL ID 10c10ae1-2b66-f708-e063-6394a90a0fcaSPL set ID b2fe7f47-1a2e-40ee-8f8f-38f2028dce1bRxCUI 198440, 200977UNII 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

N400135060901 followed by a unit qualifier and the quantity

Package 00135-0609-01. 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: headache backache muscular aches minor arthritis pain temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
equate pain relieveracetaminophenAcetaminophen 325 mg/1TabletOralWALMART INC.79903-299
Unishield AspirinaspirinAspirin 325 mg/1Tablet, Film coatedOralUnishield49314-1163
dg health aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralDolgencorp, LLC55910-467
Nite-Time COLD/FLU ORIGINALacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralSalado Sales, Inc.57243-501
Aspirina Cafeinaaspirin,caffeineCaffeine 32.5 mg/1; Aspirin 500 mg/1TabletOralBayer HealthCare LLC.0280-0162
Aspirin Low Dose Safety CoatedaspirinAspirin 81 mg/1Tablet, CoatedOralCare One (Retail Business Services, LLC.)72476-263
AcetaminophenAcetaminophen 500 mg/1TabletOralWALMART INC79903-296
Dolex Children Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralPharmadel LLC55758-026
Acetaminophen PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralWinCo Foods, LLC67091-137
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, ChewableOralWalgreen Company0363-0218
AcetaminophenAcetaminophen 500 mg/1TabletOralMeijer Distribution Inc79481-0780
Children Acetaminophen Oral SolutionacetaminophenAcetaminophen 160 mg/5mLLiquidOralMAJOR PHARMACEUTICALS0904-7014
Headache Relief Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTabletOralSafeway, Inc.21130-586
Back and Body Extra Strengthaspirin, caffeineAspirin 500 mg/1; Caffeine 32.5 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-143
TYLENOL Extra StrengthacetaminophenAcetaminophen 960 mg/30mLSuspensionOralKenvue Brands LLC50580-187
AcetaminophenAcetaminophen 325 mg/1TabletOralProstat First Aid58228-0061
Aspirin 81mgaspirin enteric coated tablets 81mgAspirin 81 mg/1TabletOralVITANE PHARMACEUTICALS, INC60577-807
Acetaminophen PMacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralCOSTCO WHOLESALE CORPORATION63981-056
Childrens Pain and Fever, Grape flavoracetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreen Company0363-0323
Amazon Basics AcetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralAmazon.com Services LLC72288-008

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