NDC 50580-600

TYLENOL Regular Strength

Acetaminophen

TYLENOL Regular 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: 50580-600_e292b578-1351-d97e-e053-2a95a90aa29b
• NDC: 50580-600
• Product Type: Human Otc Drug
• Proprietary Name: TYLENOL Regular Strength
• Generic Name: Acetaminophen
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-31
• 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: 325 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50580-600-01

50 TABLET, FILM COATED in 1 BOTTLE (50580-600-01)

• Marketing Start Date: 2017-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-600-02 [50580060002]

TYLENOL Regular Strength TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-31

NDC 50580-600-01 [50580060001]

TYLENOL Regular Strength TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-31

NDC 50580-600-03 [50580060003]

TYLENOL Regular Strength TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 511536b2-6cbd-463e-b2db-6feec474cf6b
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 313782
  • 209387

NDC Crossover Matching brand name "TYLENOL Regular Strength" or generic name "Acetaminophen"

NDC	Brand Name	Generic Name
50580-487	Tylenol Regular Strength	Tylenol Regular Strength
50580-496	TYLENOL Regular Strength	TYLENOL Regular Strength
50580-600	TYLENOL Regular Strength	TYLENOL Regular Strength
50580-501	TYLENOL Regular Strength	TYLENOL Regular Strength
50580-495	TYLENOL Regular Strength	TYLENOL Regular Strength
70518-2798	TYLENOL Regular Strength	TYLENOL Regular Strength
50580-458	TYLENOL Regular Strength	TYLENOL Regular 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