FDA.reportPublic FDA data

Midol Complete

Product NDC
0280-8005
11-digit product format
002808005
Labeler code
0280
Product ID
0280-8005_32714ca6-82e9-932c-e063-6394a90ae97d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M027
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-10
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
Midol 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
ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a324Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-8005-01Midol Complete2 in 1 POUCHTABLET27
0280-8005-01Midol Complete10 in 1 CARTONTABLET107
0280-8005-02Midol Complete2 in 1 POUCHTABLET27
0280-8005-02Midol Complete25 in 1 CARTONTABLET257
0280-8005-04Midol Complete2 in 1 POUCHTABLET27
0280-8005-16Midol Complete2 in 1 CARTONTABLET27
0280-8005-16Midol Complete8 in 1 BLISTER PACKTABLET87
0280-8005-24Midol Complete8 in 1 BLISTER PACKTABLET87
0280-8005-24Midol Complete3 in 1 CARTONTABLET37
0280-8005-40Midol Complete1 in 1 CARTONTABLET17
0280-8005-40Midol Complete40 in 1 BOTTLETABLET407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-8005-16EA - Each0280-8005dcbec074-9880-48e9-96d8-049649c185be12018-04-19
0280-8005-24EA - Each0280-8005eaea4dec-a037-41d2-b348-b5491e1f119912018-04-19
0280-8005-40EA - Each0280-80057092f7e0-408c-4e14-a65c-d4ba66cb33dd12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZAMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CaffeineACTIVE MOIETY3G6A5W338EMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PYRILAMINEACTIVE MOIETYHPE317O9TLMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SHELLACINACTIVE INGREDIENT46N107B71OMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-8005MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 11 package rows20250411_ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a324.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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3242025-04-10WarningsExact identifier
application number: M027
ndc (product): 0280-8005
Diurex Water PillsCAFFEINE, MAGNESIUM SALICYLATEKobayashi Healthcare International, Inc.e02a39f9-1c8c-4d38-b394-3f5b7062932c2025-04-10WarningsExact identifier
application number: M027
Cramp TabsACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATEJHK DBA American Safety & First Aidc090807d-03b7-42d4-be41-f6240a3b330f2024-10-04WarningsExact identifier
application number: M027

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN0c09a178-1a07-4079-b4a6-d1657cb8e7147
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNcabd10f2-a91e-4406-9249-915e306c867b7
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3247
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD0c09a178-1a07-4079-b4a6-d1657cb8e7147
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3247
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDcabd10f2-a91e-4406-9249-915e306c867b7
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY0c09a178-1a07-4079-b4a6-d1657cb8e7147
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYcabd10f2-a91e-4406-9249-915e306c867b7
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3247
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN15176109-782e-4208-bb21-2f62da4a6dfa5
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN9f2c6021-a944-478b-81c1-ec86824ee7a55
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD15176109-782e-4208-bb21-2f62da4a6dfa5
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD9f2c6021-a944-478b-81c1-ec86824ee7a55
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY15176109-782e-4208-bb21-2f62da4a6dfa5
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY9f2c6021-a944-478b-81c1-ec86824ee7a55
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN3ca96ed9-d9af-dbfe-e063-6394a90a29322
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNf7bf126d-a6f1-231a-e053-6294a90a04e12
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD3ca96ed9-d9af-dbfe-e063-6394a90a29322
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDf7bf126d-a6f1-231a-e053-6294a90a04e12
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYf7bf126d-a6f1-231a-e053-6294a90a04e12
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY3ca96ed9-d9af-dbfe-e063-6394a90a29322
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN8d6edcac-504b-d437-e053-2995a90a6b7a1
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN3fc2d123-6b1c-45dc-b5ed-c7a9b7ade6b81
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN1bf96671-9233-4b17-9d4c-d26982ca45be1
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD8d6edcac-504b-d437-e053-2995a90a6b7a1
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD3fc2d123-6b1c-45dc-b5ed-c7a9b7ade6b81
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD1bf96671-9233-4b17-9d4c-d26982ca45be1
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY8d6edcac-504b-d437-e053-2995a90a6b7a1
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY3fc2d123-6b1c-45dc-b5ed-c7a9b7ade6b81
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY1bf96671-9233-4b17-9d4c-d26982ca45be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-8005-010028080050110 POUCH in 1 CARTON (0280-8005-01) / 2 TABLET in 1 POUCH10 pouch2023-04-26NoNoCurrent
0280-8005-020028080050225 POUCH in 1 CARTON (0280-8005-02) / 2 TABLET in 1 POUCH25 pouch2023-04-26NoNoCurrent
0280-8005-04002808005042 TABLET in 1 POUCH (0280-8005-04) 2 tablet2023-04-26NoNoCurrent
0280-8005-16002808005162 BLISTER PACK in 1 CARTON (0280-8005-16) / 8 TABLET in 1 BLISTER PACK2 blister pack2014-02-100000-00-00NoNoCurrent
0280-8005-24002808005243 BLISTER PACK in 1 CARTON (0280-8005-24) / 8 TABLET in 1 BLISTER PACK3 blister pack2014-02-100000-00-00NoNoCurrent
0280-8005-40002808005401 BOTTLE in 1 CARTON (0280-8005-40) / 40 TABLET in 1 BOTTLE1 bottle2014-02-100000-00-00NoNoCurrent