FDA.reportPublic FDA data

Midol Complete

Product NDC
66715-9745
11-digit product format
667159745
Labeler code
66715
Product ID
66715-9745_459c02cd-5843-bb52-e063-6394a90a7365
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine, and Pyrilamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-01
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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiR35D29L3ZA, 362O9ITL9D, 3G6A5W338E
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
66715-9745-2Midol Complete2 in 1 CARTONTABLET29
66715-9745-2Midol Complete2 in 1 POUCHTABLET29

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
CaffeineACTIVE INGREDIENT3G6A5W338EMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Pyrilamine MaleateACTIVE INGREDIENTR35D29L3ZAMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
AcetaminophenACTIVE MOIETY362O9ITL9DMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
CaffeineACTIVE MOIETY3G6A5W338EMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
PyrilamineACTIVE MOIETYHPE317O9TLMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
ShellacINACTIVE INGREDIENT46N107B71OMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1
TriacetinINACTIVE INGREDIENTXHX3C3X673MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9745MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET MIDOL COMPLETE, TRAVEL BASIX (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC]8Current NDC, Legacy NDC, 2 package rows20240723_d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca9
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca9
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9745-2667159745022 POUCH in 1 CARTON (66715-9745-2) / 2 TABLET in 1 POUCH2 pouch2011-12-010000-00-00NoNoCurrent