Home NDC 0280-0078 Midol Complete Caffeine Free
Product NDC 0280-0078
11-digit product format 002800078
Labeler code 0280
Product ID 0280-0078_45264d78-173d-fa9d-e063-6294a90ae983
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
Dosage form TABLET
Route ORAL
Labeler Bayer HealthCare LLC.
Application M027
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-29
Substance ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
Active strength 500; 25; 15 mg/1; mg/1; mg/1
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 Caffeine Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 PAMABROM 25 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 UA8U0KJM72 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 1052637 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 0280-0078-01 Midol Complete Caffeine Free 4 in 1 BLISTER PACK TABLET 4 2 0280-0078-01 Midol Complete Caffeine Free 6 in 1 CARTON TABLET 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0078 MIDOL COMPLETE CAFFEINE FREE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC.] 1 Current NDC, 2 package rows 20240517_177d78c7-871c-cb39-e063-6394a90aab24.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 Sample Exclude flag Status 0280-0078-01 00280007801 6 BLISTER PACK in 1 CARTON (0280-0078-01) / 4 TABLET in 1 BLISTER PACK 6 blister pack 2021-01-29 No No Current