NDC 0904-6738

Acetaminophen Oral Solution

Acetaminophen Oral Solution

Acetaminophen Oral Solution is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Acetaminophen.

Product ID0904-6738_81f54766-2e85-3885-e053-2991aa0a518a
NDC0904-6738
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Oral Solution
Generic NameAcetaminophen Oral Solution
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-04-08
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameMajor Pharmaceuticals
Substance NameACETAMINOPHEN
Active Ingredient Strength160 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6738-70

10 TRAY in 1 CASE (0904-6738-70) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2019-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6738-70 [00904673870]

Acetaminophen Oral Solution SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-04-08

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:81f30812-60c2-65c0-e053-2991aa0afed6
Manufacturer
UNII
UPC Code
  • 0309046738701
  • 0309046741725
  • 0309046739715
  • 0309046740704
  • 0309046820765
  • NDC Crossover Matching brand name "Acetaminophen Oral Solution" or generic name "Acetaminophen Oral Solution"

    NDCBrand NameGeneric Name
    0904-6738Acetaminophen Oral SolutionAcetaminophen Oral Solution
    0904-6739Acetaminophen Oral SolutionAcetaminophen Oral Solution
    0904-6820Acetaminophen Oral SolutionAcetaminophen Oral Solution
    55154-3360Acetaminophen Oral SolutionAcetaminophen Oral Solution
    55154-3553Acetaminophen Oral SolutionAcetaminophen Oral Solution
    55154-8088Acetaminophen Oral SolutionAcetaminophen Oral Solution
    55154-9417Acetaminophen Oral SolutionAcetaminophen
    62320-311Childrens Pain Relief and Fever ReducerAcetaminophen Oral Solution

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