Home NDC 55758-326 Dolex Fem
Product NDC 55758-326
11-digit product format 557580326
Labeler code 55758
Product ID 55758-326_4a169436-bb76-aceb-e063-6394a90a557f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine, Pyrilamine Maleate
Dosage form TABLET, COATED
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Additional Listing Data#
Finished product Yes
Brand name base Dolex Fem
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-326-02 Dolex Fem 2 in 1 PACKET TABLET, COATED 2 13 55758-326-25 Dolex Fem 1 in 1 CARTON TABLET, COATED 1 13 55758-326-25 Dolex Fem 24 in 1 BLISTER PACK TABLET, COATED 24 13 55758-326-50 Dolex Fem 25 in 1 BOX TABLET, COATED 25 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-326 DOLEX FEM (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [PHARMADEL LLC] 11 Current NDC, Legacy NDC, 4 package rows 20250206_b1cab10b-19f1-f5d5-e053-2995a90a4d5f.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 1 of 84 · 1,678 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 55758-326-02 55758032602 2 in 1 PACKET Historical 55758-326-24 55758032624 1 BOTTLE in 1 CARTON (55758-326-24) > 24 TABLET, COATED in 1 BOTTLE 1 bottle 2020-10-01 0000-00-00 No No Current 55758-326-25 55758032625 1 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2020-10-01 0000-00-00 No No Current 55758-326-50 55758032650 25 in 1 BOX Historical