NDC 50580-325

Infants TYLENOL

Acetaminophen

Infants TYLENOL is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen.

• Product ID: 50580-325_887a323a-083d-4c8a-9030-04c376a0b619
• NDC: 50580-325
• Product Type: Human Otc Drug
• Proprietary Name: Infants TYLENOL
• Generic Name: Acetaminophen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2017-09-25
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: ACETAMINOPHEN
• Active Ingredient Strength: 160 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50580-325-01

1 BOTTLE in 1 CARTON (50580-325-01) > 60 mL in 1 BOTTLE

• Marketing Start Date: 2017-09-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-325-01 [50580032501]

Infants TYLENOL SUSPENSION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-09-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

OpenFDA Data

• SPL SET ID: 997b9551-c222-4a9c-8ba1-09a5f97495fa
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 828555
  • 307668

NDC Crossover Matching brand name "Infants TYLENOL" or generic name "Acetaminophen"

NDC	Brand Name	Generic Name
50580-325	Infants TYLENOL	Infants TYLENOL
50580-599	Infants TYLENOL	Infants TYLENOL
50580-223	Infants TYLENOL	Infants TYLENOL
50580-191	Infants TYLENOL	Infants TYLENOL
50580-433	Infants TYLENOL	Infants TYLENOL
0121-0657	Acetaminophen	Acetaminophen
0113-7000	Basic Care acetaminophen	Acetaminophen
0113-7484	basic care acetaminophen	Acetaminophen
0113-7544	Basic Care Acetaminophen	Acetaminophen
0113-7130	basic care childrens pain and fever	Acetaminophen
0113-0020	good sense childrens pain and fever	Acetaminophen
0113-0212	Good Sense Childrens Pain and Fever	Acetaminophen
0113-0608	good sense childrens pain and fever	Acetaminophen
0113-0998	Good Sense Childrens Pain and Fever	Acetaminophen
0113-0161	Good Sense pain and fever	Acetaminophen
0113-0397	Good Sense Pain and Fever	acetaminophen
0113-0590	Good Sense Pain and Fever	acetaminophen
0113-0946	good sense pain and fever	Acetaminophen
0113-8959	Good Sense Pain and Fever	Acetaminophen
0113-0025	Good Sense Pain Relief	Acetaminophen
0113-0044	Good Sense Pain Relief	Acetaminophen
0113-0187	good sense pain relief	Acetaminophen
0113-0217	good sense pain relief	Acetaminophen
0113-0227	Good Sense Pain Relief	Acetaminophen
0113-0403	good sense pain relief	Acetaminophen
0113-0484	Good Sense Pain Relief	Acetaminophen
0113-0518	good sense pain relief	Acetaminophen
0113-0544	good sense pain relief	Acetaminophen
0113-1889	good sense pain relief	acetaminophen
0113-1975	Good Sense Pain Relief	Acetaminophen
0031-9301	Robitussin Direct Sore Throat Pain	acetaminophen