PMDA drug package insert

正露丸

PMDA OTC drug · キョクトウ株式会社 サンドラッグ・グループ ハピコム マツモトキヨシ · package insert Feb 13, 2024

Key facts

Brand names 正露丸
Companies 製造販売元/キョクトウ(株),販売会社/キョクトウ株式会社 サンドラッグ・グループ ハピコム マツモトキヨシ, NID,販売会社/キリン堂 明治薬品 富士薬品 コスモス ゲンキー
Product type OTC drug
OTC risk class 第2類医薬品
OTC dosage form 錠剤
OTC effect category 止瀉薬, 歯痛・歯槽膿漏薬
Package insert date Feb 13, 2024
PMDA document key 230138_J0601003043
PMDA company code 230138

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)