FDA.reportPublic FDA data

Menstrual Complete

Product NDC
50844-399
11-digit product format
508440399
Labeler code
50844
Product ID
50844-399_3b02e24f-5f0b-4dcd-aca0-bf8ed6d3307e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine, Pyrilamine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Menstrual Complete
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE60 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 3G6A5W338E, R35D29L3ZA
Rxcui1597298

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-399-08Menstrual Complete24 in 1 BOTTLE, PLASTICTABLET, FILM COATED245
50844-399-08Menstrual Complete1 in 1 CARTONTABLET, FILM COATED15
50844-399-21Menstrual Complete2 in 1 CARTONTABLET, FILM COATED25
50844-399-21Menstrual Complete8 in 1 BLISTER PACKTABLET, FILM COATED85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-399MENSTRUAL COMPLETE (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4Current NDC, 4 package rows20240825_c4a28f8f-030d-4487-b74f-13998482e72d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNc4a28f8f-030d-4487-b74f-13998482e72d5
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDc4a28f8f-030d-4487-b74f-13998482e72d5
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYc4a28f8f-030d-4487-b74f-13998482e72d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50844-399-08508440399081 BOTTLE, PLASTIC in 1 CARTON (50844-399-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-07-19NoNoCurrent
50844-399-21508440399212 BLISTER PACK in 1 CARTON (50844-399-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-07-19NoNoCurrent