NDC 50580-378

Tylenol Extra Strength

Acetaminophen

Tylenol Extra Strength is a Oral Tablet, Film Coated 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: 50580-378_06687c5d-fe46-400d-a84a-c6d755baa252
• NDC: 50580-378
• Product Type: Human Otc Drug
• Proprietary Name: Tylenol Extra Strength
• Generic Name: Acetaminophen
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-11-01
• 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: 500 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50580-378-01

1 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2014-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-378-01 [50580037801]

Tylenol Extra Strength TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-11-01

NDC 50580-378-03 [50580037803]

Tylenol Extra Strength TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-04-06

NDC 50580-378-02 [50580037802]

Tylenol Extra Strength TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-11-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	500 mg/1

OpenFDA Data

• SPL SET ID: 17cfa99d-abb2-4d77-9e0e-e77109fbb61a
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 209459
  • 198440

NDC Crossover Matching brand name "Tylenol Extra Strength" or generic name "Acetaminophen"

NDC	Brand Name	Generic Name
67751-167	Tylenol Extra Strength	Tylenol Extra Strength
50090-0005	TYLENOL Extra Strength	TYLENOL Extra Strength
50090-1695	Tylenol Extra Strength	Tylenol Extra Strength
50269-449	Tylenol Extra Strength	Tylenol Extra Strength
50580-412	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-692	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-451	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-590	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-449	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-488	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-378	Tylenol Extra Strength	Tylenol Extra Strength
66715-9747	TYLENOL EXTRA STRENGTH	TYLENOL EXTRA STRENGTH
73097-012	Tylenol Extra Strength	Tylenol Extra Strength
50580-937	Tylenol Extra Strength	Tylenol Extra Strength
50269-008	Tylenol Extra Strength	Tylenol Extra Strength
50580-457	TYLENOL Extra Strength	TYLENOL Extra Strength
50580-209	TYLENOL Extra Strength	TYLENOL Extra Strength
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