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 55 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DG Health Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE DOLGENCORP, INC 8f1343d5-2884-3a14-e053-2a95a90a2f90 2024-11-13 Warnings Exact identifier application number: M013 Good Sense Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Good Sense cd25b0c3-0134-beef-e053-2a95a90a092b 2024-11-13 Warnings Exact identifier application number: M013 Drug Mart Effervescent Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Discount Drug Mart, Inc 8bc65603-1dbf-30ab-e053-2995a90a7c15 2024-11-13 Warnings Exact identifier application number: M013 Best Choice Effervescent Antacid Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Valu Merchandisers Company 8aab905b-5fe7-dddb-e053-2995a90a6c6f 2024-11-13 Warnings Exact identifier application number: M013 Publix Fast Relief Effervescent ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Publix Super Markets Inc. 73051f16-2569-7394-e053-2991aa0a5359 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 70d265de-ff94-e0e4-e053-2a91aa0a962a 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Extra Strength Effervescent Antacid and Pain Relief ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 9f7d0c96-a561-a8a0-e053-2995a90a250b 2024-11-13 Warnings Exact identifier application number: M013 WinCo Foods Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET WinCo Foods, LLC 0c8a755a-089f-477f-97e9-0dd6fdfbe99d 2024-11-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Kroger Company 8fb19444-f0e0-4d26-81e8-6a4b835056d8 2024-11-12 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 59d01f72-4575-48e2-b914-b6a6456ca7d2 2024-11-11 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Kroger Company d181560c-1c39-4f2e-8a17-996224ca040f 2024-11-09 Warnings Exact identifier application number: M013 Childrens Tylenol ACETAMINOPHEN Kenvue Brands LLC babcb210-6a47-46ef-b4ea-bdde80411cd3 2024-11-08 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Acme United Corporation f7f9dc46-a945-7ae3-e053-6394a90a1192 2024-11-08 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC dd87e342-b0cb-4111-9f15-415dbcda4b77 2024-11-07 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 0c5fdda8-5049-46de-e063-6294a90a592b 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 46ddbfde-54ab-4373-b832-b9c0620b1e9d 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 333f6231-3778-4c1f-9558-2afddca22c86 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 34247a3b-0846-4086-becd-76e630b3b721 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC a51c2deb-c703-4dc8-9255-8ac9fe635170 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC ce0a1fbc-7345-462b-b0da-c7149bdc288c 2024-11-07 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