NDC 50580-191

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: 50580-191_cbfc00e4-66ee-4577-be27-cd2da45a0eb8
• NDC: 50580-191
• Product Type: Human Otc Drug
• Proprietary Name: Infants TYLENOL
• Generic Name: Acetaminophen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2013-05-01
• 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 50580-191-12

1 BOTTLE, PLASTIC in 1 CARTON (50580-191-12) > 60 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2014-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-191-01 [50580019101]

Infants TYLENOL SUSPENSION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-05-01

NDC 50580-191-12 [50580019112]

Infants TYLENOL SUSPENSION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-07-01

NDC 50580-191-05 [50580019105]

Infants TYLENOL SUSPENSION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-05-01
• Marketing End Date: 2013-05-21

NDC 50580-191-02 [50580019102]

Infants TYLENOL SUSPENSION

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-05-01
• Marketing End Date: 2016-12-15

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

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