FDA.reportPublic FDA data

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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct67751-145IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-14567751-145-01IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-14567751-145-02IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Listing expiration
2027-12-31

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
cabd10f2-a91e-4406-9249-915e306c867bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67751-145-012024-04-15Midol
67751-145-022024-04-15Midol
67751-145-012024-01-30Midol
67751-145-022024-01-30Midol

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

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 25 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
application number: M013
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEa73f8217-9eae-4e2a-b29c-7de3861d0e372026-01-06WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact identifier
application number: M013
Menstrual Relief Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEUnited Natural Foods, Inc. dba UNFI807598ef-9f03-48df-b076-3ee95ef4b06c2026-01-05WarningsExact identifier
application number: M013
Pain Relief Extra Strength, Non-AspirinACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1fb5e871-45fd-46fe-bf73-5192f8316e8e2026-01-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENValu Merchandisers Company0005aafa-08f8-4990-a54d-cc097195708f2026-01-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENWalmart Inc.152bb455-da5b-ae13-e063-6394a90acab02026-01-01WarningsExact identifier
application number: M013
Dr. Cocoa for Children Pain and FeverACETAMINOPHENInfirst Healthcare Inc.486ea294-6d18-a907-e063-6294a90ad2842026-01-01WarningsExact identifier
application number: M013
ED APAPACETAMINOPHENEDWARDS PHARMACEUTICALS, INC.f76d5fff-ebea-40f9-aad3-4064a0c863f02025-12-31WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP99ec63ef-aa28-c2fb-e053-2a95a90a9f6d2025-12-31WarningsExact identifier
application number: M013
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
application number: M013
Liquid AcetaminophenACETAMINOPHENLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONa7dbd4c0-53eb-4368-917b-1432c09ce6b42025-12-31WarningsExact identifier
application number: M013
Llorens Care Children AcetaminophenACETAMINOPHENLlorens Pharmaceutical International Division, Inc.2a46d7d2-293b-5024-e063-6294a90a31aa2025-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)Walgreens3a801457-c5d0-b134-e063-6294a90ac5cb2025-12-31WarningsExact identifier
application number: M013
Daytime and Nighttime Severe Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGenexa Inc.190c7eaf-dcd4-d314-e063-6294a90a6f332025-12-30WarningsExact identifier
application number: M013
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLC0181af13-da32-4431-be39-c31fdfac92022025-12-29WarningsExact 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 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