Over-the-counter drug · OTC MONOGRAPH DRUG

Children Acetaminophen (Acetaminophen) NDC 82568-0008

Acetaminophen 160 mg/5mL · Liquid · Oral · AARNA USA INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)82568-0008Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82568-0008Add 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
82568-0008-482568000804825680008041 BOTTLE in 1 PACKAGE (82568-0008-4) / 118 mL in 1 BOTTLEMarketed from Feb 18, 2025
82568-0008-68256800080682568000806473 mL in 1 BOTTLE (82568-0008-6)Marketed from Feb 18, 2025
82568-0008-882568000808825680008081 BOTTLE in 1 PACKAGE (82568-0008-8) / 236 mL in 1 BOTTLEMarketed from Feb 18, 2025

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)
Children Acetaminophen
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 160 mg/5mL
Dosage form
Liquid
Route
Oral
Labeler
AARNA USA INC.NDC labeler code 82568
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 82568-0008_354289e0-a1d5-590d-e063-6394a90a2ec3SPL ID 354289e0-a1d5-590d-e063-6394a90a2ec3SPL set ID 25bcb9d5-f388-4ae7-8037-970ffe8d17f0RxCUI 307668UNII 362O9ITL9DUPC 0382568000884

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

N482568000804 followed by a unit qualifier and the quantity

Package 82568-0008-04. 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 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 82568-0008

What is NDC 82568-0008?
82568-0008 is the product NDC for Children Acetaminophen (acetaminophen), Acetaminophen 160 mg/5mL liquid, listed with the FDA by AARNA USA INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Children Acetaminophen (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
AARNA USA INC., NDC labeler code 82568. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Children Acetaminophen?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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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