dolex fem

Generic: acetaminophen, caffeine, pyrilamine maleate

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dolex fem
Generic Name acetaminophen, caffeine, pyrilamine maleate
Labeler pharmadel llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, caffeine 60 mg/1, pyrilamine maleate 15 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-326
Product ID 55758-326_4a169436-bb76-aceb-e063-6394a90a557f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2020-10-01

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc] methylxanthine [epc]
Chemical Structure
xanthines [cs]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758326
Hyphenated Format 55758-326

Supplemental Identifiers

RxCUI
1597298
UNII
362O9ITL9D 3G6A5W338E R35D29L3ZA
NUI
N0000175739 N0000175729 N0000175790 M0023046

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dolex fem (source: ndc)
Generic Name acetaminophen, caffeine, pyrilamine maleate (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 60 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55758-326-25 1 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (500 mg/1) caffeine (60 mg/1) pyrilamine maleate (15 mg/1)

Linked Drug Pages (1)

Dolex Fem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a169436-bb76-aceb-e063-6394a90a557f", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "3G6A5W338E", "R35D29L3ZA"], "rxcui": ["1597298"], "spl_set_id": ["b1cab10b-19f1-f5d5-e053-2995a90a4d5f"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55758-326-25)  / 24 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "55758-326-25", "marketing_start_date": "20201001"}], "brand_name": "Dolex Fem", "product_id": "55758-326_4a169436-bb76-aceb-e063-6394a90a557f", "dosage_form": "TABLET, COATED", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "55758-326", "generic_name": "Acetaminophen, Caffeine, Pyrilamine Maleate", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dolex Fem", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CAFFEINE", "strength": "60 mg/1"}, {"name": "PYRILAMINE MALEATE", "strength": "15 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201001", "listing_expiration_date": "20271231"}