Home NDC 0280-8015 Midol Complete
Product NDC 0280-8015
11-digit product format 002808015
Labeler code 0280
Product ID 0280-8015_4526be49-a733-1db7-e063-6394a90a1937
Type HUMAN OTC DRUG
Nonproprietary name Midol Complete
Dosage form TABLET, COATED
Route ORAL
Labeler Bayer HealthCare LLC
Application M027
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-15
Substance CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN
Active strength 60; 15; 500 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 2026-12-31
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
Brand name suffix Gelcaps
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 60 mg/1 PYRILAMINE MALEATE 15 mg/1 ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup R35D29L3ZA Internal UNII lookup 362O9ITL9D 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-8015-24 Midol CompleteGelcaps 3 in 1 CARTON TABLET, COATED 3 6 0280-8015-24 Midol CompleteGelcaps 24 in 1 BLISTER PACK TABLET, COATED 24 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 PYRILAMINE MALEATE ACTIVE INGREDIENT R35D29L3ZA MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 PYRILAMINE ACTIVE MOIETY HPE317O9TL MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-8015 MIDOL COMPLETE GELCAPS (MIDOL COMPLETE) TABLET, COATED [BAYER HEALTHCARE LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231201_0a4477ce-0a02-197d-e054-00144ff88e88.zip
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 · 43 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-8015-24 00280801524 3 BLISTER PACK in 1 CARTON (0280-8015-24) / 24 TABLET, COATED in 1 BLISTER PACK 3 blister pack 2014-12-15 0000-00-00 No No Current