Home NDC 85237-1841 Midol Complete
Product NDC 85237-1841
11-digit product format 852371841
Labeler code 85237
Product ID 85237-1841_55bc3945-3864-e797-e063-6394a90a2f87
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
Dosage form TABLET
Route ORAL
Labeler Select Consumer Group
Application M027
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-02-10
Substance ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength 500; 60; 15 mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Midol Complete
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CAFFEINE 60 mg/1 PYRILAMINE MALEATE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 3G6A5W338E Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1597298 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 3 of 3 · 45 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diurex Ultra CAFFEINE Kobayashi Healthcare International, Inc. 9a035265-40c6-43f5-8de6-6bece8449840 2025-04-14 Warnings Exact identifier application number: M027 Diurex Max PAMABROM Kobayashi Healthcare International, Inc. 37dfece3-d570-4ab2-ba95-af6eb1f3acd4 2025-04-11 Warnings Exact identifier application number: M027 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE Bayer HealthCare LLC. ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a324 2025-04-10 Warnings Exact identifier application number: M027 Diurex Water Pills CAFFEINE, MAGNESIUM SALICYLATE Kobayashi Healthcare International, Inc. e02a39f9-1c8c-4d38-b394-3f5b7062932c 2025-04-10 Warnings Exact identifier application number: M027 Cramp Tabs ACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATE JHK DBA American Safety & First Aid c090807d-03b7-42d4-be41-f6240a3b330f 2024-10-04 Warnings Exact identifier application number: M027
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85237-1841-1 85237184101 1 POUCH in 1 BLISTER PACK (85237-1841-1) / 2 TABLET in 1 POUCH 1 pouch 2014-02-10 No No Current 85237-1841-2 85237184102 2 POUCH in 1 BLISTER PACK (85237-1841-2) / 2 TABLET in 1 POUCH 2 pouch 2014-02-10 No No Current 85237-1841-3 85237184103 20 POUCH in 1 BOX, UNIT-DOSE (85237-1841-3) / 2 TABLET in 1 POUCH 20 pouch 2014-02-10 No No Current 85237-1841-4 85237184104 25 POUCH in 1 BOX, UNIT-DOSE (85237-1841-4) / 2 TABLET in 1 POUCH 25 pouch 2014-02-10 No No Current 85237-1841-5 85237184105 30 POUCH in 1 BOX, UNIT-DOSE (85237-1841-5) / 2 TABLET in 1 POUCH 30 pouch 2014-02-10 No No Current