Midol

Product NDC
67751-145
11-digit product format
677510145
Labeler code
67751
Product ID
67751-145_4efb2a06-f0fb-b6d2-e063-6294a90a92d4
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Midol
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-145-012024-04-15C16284748780-11030e365-4fea-111a-e063-dadaa90a10e2Midol
67751-145-022024-04-15C16284748780-11030e365-4fea-111a-e063-dadaa90a10e2Midol
67751-145-012024-01-30C16284748780-11030e365-4fea-111a-e063-dadaa90a10e2Midol
67751-145-022024-01-30C16284748780-11030e365-4fea-111a-e063-dadaa90a10e2Midol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-145-01Midol2 in 1 CARTONTABLET27
67751-145-01Midol2 in 1 POUCHTABLET27
67751-145-02Midol2 in 1 CARTONTABLET27
67751-145-02Midol4 in 1 POUCHTABLET47
67751-145-06Midol2 in 1 POUCHTABLET27
67751-145-06Midol3 in 1 CARTONTABLET37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-145MIDOL (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]6Current NDC, Legacy NDC, 6 package rows20241004_cabd10f2-a91e-4406-9249-915e306c867b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletSCDcabd10f2-a91e-4406-9249-915e306c867b7
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYcabd10f2-a91e-4406-9249-915e306c867b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-145-01677510145012 POUCH in 1 CARTON (67751-145-01) / 2 TABLET in 1 POUCH2 pouch2016-09-190000-00-00NoNoCurrent
67751-145-02677510145022 POUCH in 1 CARTON (67751-145-02) / 4 TABLET in 1 POUCH2 pouch2016-09-190000-00-00NoNoCurrent
67751-145-06677510145063 POUCH in 1 CARTON (67751-145-06) / 2 TABLET in 1 POUCH3 pouch2025-05-09NoNoCurrent