Home NDC 83049-489 FLO PMS Complete
Product NDC 83049-489
11-digit product format 830490489
Labeler code 83049
Product ID 83049-489_a0526808-00a6-42a5-aeb8-42db54626a28
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine, Pyrilamine maleate
Dosage form TABLET
Route ORAL
Labeler O Positiv, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-05
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 FLO PMS 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83049-489-08 FLO PMS Complete 8 in 1 BLISTER PACK TABLET 8 4 83049-489-08 FLO PMS Complete 3 in 1 CARTON TABLET 3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83049-489 FLO PMS COMPLETE (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET [O POSITIV, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231010_cce62d9f-adb1-4473-8258-910dff6b1378.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 64 of 79 · 1,579 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 83049-489-08 83049048908 3 BLISTER PACK in 1 CARTON (83049-489-08) / 8 TABLET in 1 BLISTER PACK 3 blister pack 2022-12-05 0000-00-00 No No Current