Over-the-counter drug · OTC MONOGRAPH DRUG

Childrens Acetaminophen (Acetaminophen) NDC 0904-7278

Acetaminophen 160 mg/5mL · Suspension · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7278Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7278Add 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
0904-7278-70009047278700090472787010 TRAY in 1 CASE (0904-7278-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7278-41)Marketed from Jun 2, 2023

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)
Childrens Acetaminophen
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 160 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 0904-7278_574dcd8d-5656-4748-bc1e-7331fe2b8b44SPL ID 574dcd8d-5656-4748-bc1e-7331fe2b8b44SPL set ID 38b839b6-de7d-4f33-a19a-efc92cdad92cRxCUI 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

N400904727870 followed by a unit qualifier and the quantity

Package 00904-7278-70. 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)

Do not Use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product, do not exceed the recommended dose (see overdose warning) Stop use and ask a doctor if : • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7278

What is NDC 0904-7278?
0904-7278 is the product NDC for Childrens Acetaminophen (acetaminophen), Acetaminophen 160 mg/5mL suspension, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Acetaminophen (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Acetaminophen?
18 other product NDCs are listed under this name. See all Childrens Acetaminophen 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 Childrens Acetaminophen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/1Tablet, ChewableOralGeri-Care Pharmaceutical Corp57896-15557896-0155-24
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralGrocery Outlet, Inc.85828-92285828-0922-05
CHILDRENS AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralKesin Pharma Corporation81033-02681033-0026-0181033-0026-0281033-0026-05+5 more
Childrens Acetaminophenchildren acetaminophen cherryAcetaminophen 160 mg/5mLSuspensionOralAARNA USA INC.82568-001182568-0011-0282568-0011-0482568-0011-06+1 more
Childrens Acetaminophenchildrens acetaminophen oralAcetaminophen 160 mg/5mLSuspensionOralAARNA USA INC.82568-001082568-0010-0282568-0010-0482568-0010-06+1 more
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralAdvagen Pharma Limited72888-45972888-0459-01
childrens acetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralMajor Pharmaceuticals0904-744500904-7445-20
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-839768788-8397-01
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralPadagis Israel Pharmaceuticals Ltd45802-20145802-0201-26
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralProficient Rx LP71205-26371205-0263-04

All 19 Childrens Acetaminophen 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
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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