NDC 50580-612

Childrens TYLENOL

Acetaminophen

Childrens 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: 50580-612_001620c2-afd6-4490-b532-292308487989
• NDC: 50580-612
• Product Type: Human Otc Drug
• Proprietary Name: Childrens TYLENOL
• Generic Name: Acetaminophen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-01
• 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: 2020-12-31

Packaging

NDC 50580-612-01

1 BOTTLE in 1 CARTON (50580-612-01) > 120 mL in 1 BOTTLE

• Marketing Start Date: 2016-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-612-02 [50580061202]

Childrens TYLENOL SUSPENSION

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-03

NDC 50580-612-01 [50580061201]

Childrens TYLENOL SUSPENSION

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

OpenFDA Data

• SPL SET ID: d8aa3b1a-5f63-49db-998c-35cd11bd733f
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 828555
  • 307668

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

NDC	Brand Name	Generic Name
50580-170	Childrens TYLENOL	Childrens TYLENOL
50580-424	Childrens TYLENOL	Childrens TYLENOL
50580-460	Childrens Tylenol	Childrens Tylenol
50580-614	Childrens TYLENOL	Childrens TYLENOL
50580-438	Childrens TYLENOL	Childrens TYLENOL
50580-579	Childrens TYLENOL	Childrens TYLENOL
50580-612	Childrens TYLENOL	Childrens TYLENOL
50580-521	Childrens TYLENOL	Childrens TYLENOL
50580-123	Childrens TYLENOL	Childrens TYLENOL
50580-296	Childrens TYLENOL	Childrens TYLENOL
50580-509	Childrens TYLENOL	Childrens TYLENOL
50580-522	Childrens Tylenol	Childrens Tylenol
50580-555	Childrens TYLENOL	Childrens 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