FDA.reportPublic FDA data

MENSTRUAL COMPLETE

Product NDC
69168-470
11-digit product format
691680470
Labeler code
69168
Product ID
69168-470_6e554ca0-5318-4b25-a548-e0a74b3dcb16
Type
HUMAN OTC DRUG
Nonproprietary name
Menstrual Complete
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allegiant Health
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-05
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

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
MENSTRUAL COMPLETE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1597298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d197b886-67e4-4aba-8582-305576c07604Available on FDA.report

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
69168-470-06MENSTRUAL COMPLETE120 in 1 BOTTLETABLET, FILM COATED1202
69168-470-82MENSTRUAL COMPLETE90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-470MENSTRUAL COMPLETE TABLET, FILM COATED [ALLEGIANT HEALTH]2Current NDC, 2 package rows20241122_d197b886-67e4-4aba-8582-305576c07604.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 71 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC0faa3592-4d56-4645-9a0e-066e0bdfebb62024-04-05WarningsExact identifier
application number: M013
Pain Relief Childrens Dye FreeACETAMINOPHENH E B3f9beeeb-5e27-4b81-a647-20e65f0e9fc92024-04-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINH E Bedb321dd-e5cb-4031-a8a8-efce9e86fe162024-04-03WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENH E Ba0c0277e-50aa-4328-8f93-ab20c6176b2b2024-04-03WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINBryant Ranch Prepackbda805ab-7f37-405d-a144-4e06ad9a29a12024-04-03WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)650cb15e-c448-4df3-b0f8-4398be05d8412024-03-27WarningsExact identifier
application number: M013
Good Sense Effervescent Pain ReliefASPIRINPerrigo Direct, Inc.103027a7-2f0e-8d8c-e063-6294a90aedc72024-03-26WarningsExact identifier
application number: M013
rugby infants acetaminophenACETAMINOPHENRugby Laboratories8aa9ac68-ca61-4163-a876-52034138c1ea2024-03-25WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc08a18481-f029-f01f-e063-6294a90aac652024-03-21WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc0d106fa2-2a77-deb2-e063-6394a90a2dac2024-03-21WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)872c5220-a379-4dc1-b99c-f11ebb82db352024-03-19WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)79886972-47a4-44c5-a131-1a691a3281032024-03-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5ffcc78d-9163-4cb4-8811-ae9f0142806a2024-03-18WarningsExact identifier
application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERHF Acquisition Co LLC, DBA HealthFirst13e621dc-b2b4-98fd-e063-6394a90acc752024-03-17WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INC097a9c98-a092-400d-9600-6797b0b9a50c2024-03-15WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
application number: M013
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNd197b886-67e4-4aba-8582-305576c076042
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDd197b886-67e4-4aba-8582-305576c076042
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYd197b886-67e4-4aba-8582-305576c076042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69168-470-0669168047006120 TABLET, FILM COATED in 1 BOTTLE (69168-470-06) 2024-11-05NoNoCurrent
69168-470-826916804708290 TABLET, FILM COATED in 1 BOTTLE (69168-470-82) 2024-11-05NoNoCurrent