NDC 70264-028

TYLENOL PM EXTRA STRENGTH

Acetaminophen

TYLENOL PM EXTRA STRENGTH is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by R J General Corporation. The primary component is Acetaminophen; Diphenhydramine Hydrochloride.

Product ID70264-028_eff1f6eb-680a-29e1-e053-2995a90a3d38
NDC70264-028
Product TypeHuman Otc Drug
Proprietary NameTYLENOL PM EXTRA STRENGTH
Generic NameAcetaminophen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-05-01
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart343
Labeler NameR J General Corporation
Substance NameACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70264-028-01

50 POUCH in 1 BOX (70264-028-01) > 2 TABLET, FILM COATED in 1 POUCH
Marketing Start Date2021-05-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TYLENOL PM EXTRA STRENGTH" or generic name "Acetaminophen"

NDCBrand NameGeneric Name
50580-833TYLENOL PM Extra StrengthTYLENOL PM Extra Strength
50580-608Tylenol PM Extra StrengthTylenol PM Extra Strength
67414-608Tylenol PM Extra StrengthTylenol PM Extra Strength
0121-0657AcetaminophenAcetaminophen
0113-7000Basic Care acetaminophenAcetaminophen
0113-7484basic care acetaminophenAcetaminophen
0113-7544Basic Care AcetaminophenAcetaminophen
0113-7130basic care childrens pain and feverAcetaminophen
0113-0020good sense childrens pain and feverAcetaminophen
0113-0212Good Sense Childrens Pain and FeverAcetaminophen
0113-0608good sense childrens pain and feverAcetaminophen
0113-0998Good Sense Childrens Pain and FeverAcetaminophen
0113-0161Good Sense pain and feverAcetaminophen
0113-0397Good Sense Pain and Feveracetaminophen
0113-0590Good Sense Pain and Feveracetaminophen
0113-0946good sense pain and feverAcetaminophen
0113-8959Good Sense Pain and FeverAcetaminophen
0113-0025Good Sense Pain ReliefAcetaminophen
0113-0044Good Sense Pain ReliefAcetaminophen
0113-0187good sense pain reliefAcetaminophen
0113-0217good sense pain reliefAcetaminophen
0113-0227Good Sense Pain ReliefAcetaminophen
0113-0403good sense pain reliefAcetaminophen
0113-0484Good Sense Pain ReliefAcetaminophen
0113-0518good sense pain reliefAcetaminophen
0113-0544good sense pain reliefAcetaminophen
0113-1889good sense pain reliefacetaminophen
0113-1975Good Sense Pain ReliefAcetaminophen
0031-9301Robitussin Direct Sore Throat Painacetaminophen

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.