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.
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 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 52 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join acetaminophen ACETAMINOPHEN UNFI e689c9e3-dd4d-c646-e053-2a95a90a4b6a 2024-12-09 Warnings Exact identifier application number: M013 DrKids Childrens Pain and Fever ACETAMINOPHEN 80MG/PIECE CalmCo LLC ff4b0528-39a0-80d5-e053-6394a90a8a83 2024-12-07 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 2024-12-05 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DISCOUNT DRUG MART e6feff0a-3347-194d-e053-2a95a90acd20 2024-12-05 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DISCOUNT DRUG MART e6fee238-0b6f-cb84-e053-2995a90a361b 2024-12-05 Warnings Exact identifier application number: M013 Menstrual Complete Maximum Strength ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE L.N.K. International, Inc. 379ef03c-3b6a-40c3-b736-99f0537d26c8 2024-12-05 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Marc Glassman, Inc. 43bf297f-2832-424f-a013-4bfa1d6c03e6 2024-12-04 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. 5a68ab98-720c-479a-a60a-4e594add6c09 2024-12-04 Warnings Exact identifier application number: M013 HEB Effervescent Pain Relief ASPIRIN H. E. BUTT GROCERY COMPANY 03876c71-60ec-3280-e063-6294a90a62dc 2024-12-03 Warnings Exact identifier application number: M013 Migrafein FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028875c9-4129-ce2c-e063-6294a90a26cc 2024-12-03 Warnings Exact identifier application number: M013 Neo-Lubrina Fuerte ACETAMINOPHEN, CAFFEINE OPMX LLC 0288a327-fd4b-1991-e063-6294a90ace50 2024-12-03 Warnings Exact identifier application number: M013 CAFIZETAMOL FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028771d3-a514-f7a5-e063-6394a90ac4f3 2024-12-03 Warnings Exact identifier application number: M013 Buscapina ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE OPMX LLC 048c4b03-1cf4-b724-e063-6294a90a1cad 2024-12-03 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC ecd6df7e-e7e2-446b-85ef-25971281fe31 2024-12-03 Warnings Exact identifier application number: M013 Market Basket Effervescent Pain Relief ASPIRIN DEMOULAS SUPER MARKETS, INC. 08133bf0-3c8f-e4d0-e063-6294a90af79a 2024-12-03 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN WinCo Foods, LLC 4359da13-e851-440b-91b9-6b544bff20d2 2024-12-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN WinCo Foods, LLC 5b3e8a78-5357-42ad-811e-b2578b25dc7b 2024-12-03 Warnings Exact identifier application number: M013 Low Strength Chewable Aspirin ASPIRIN Geri-Care Pharmaceutical Corp cc77b9d1-7874-4ce8-a763-3a0e1c2891de 2024-12-03 Warnings Exact identifier application number: M013 Good Sense Childrens Pain and Fever ACETAMINOPHEN L. Perrigo Company c6b79501-d08b-4430-9545-70da5f545975 2024-12-03 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 2024-12-02 Warnings Exact identifier application number: M013
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