FDA.reportPublic FDA data

MIDOL COMPLETE

Product NDC
70264-012
Requested package NDC
70264-012-01
11-digit product format
702640012
Labeler code
70264
Product ID
70264-012_43c8728c-3666-eb53-e063-6294a90af230
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, caffeine, and pyrilamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
R J General Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-10
Substance
PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE
Active strength
15; 500; 60 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

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
PYRILAMINE MALEATE15 mg/1
ACETAMINOPHEN500 mg/1
CAFFEINE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R35D29L3ZAInternal UNII lookup
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal 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
0c09a178-1a07-4079-b4a6-d1657cb8e714Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70264-012-012022-12-26C16284748780-19d75b9d0-bb1e-f424-e053-dadaa90a57ceMIDOL ® COMPLETE
70264-012-012020-01-31C16284748780-19d75b9d0-bb1e-f424-e053-dadaa90a57ceMIDOL ® COMPLETE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-012-01MIDOL COMPLETE50 in 1 CARTONTABLET507
70264-012-01MIDOL COMPLETE2 in 1 POUCHTABLET27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-012MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [R J GENERAL CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241030_0c09a178-1a07-4079-b4a6-d1657cb8e714.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 60 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Regular StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1462b308-a6a5-49ca-ab29-cacbf62caf0b2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf3db8598-fe0e-4c53-a023-5f5f8f002cc62024-10-17WarningsExact identifier
application number: M013
acetaminophen pm extra strengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIf86a11af-6d3c-4638-870d-a663ddf493712024-10-17WarningsExact identifier
application number: M013
Acetaminophen Gelcaps Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI3588a3ef-a493-43ed-96e0-c259f0d087db2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCa2186895-944b-48cb-b3c2-eac208866c342024-10-17WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC6a5d43c8-f4b7-4447-b2e1-53eb12208ef02024-10-17WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC32cc6e05-84c1-4710-bebc-cb6e7133dc542024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC2ca87a29-1f54-4da4-a66f-3b3dd4f0396c2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINKroger Company453f62d5-f580-4d19-bfae-4f78c2a6b6d62024-10-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
application number: M013
ASPIRINASPIRINFSA Store Inc.062e7b7b-d052-82b0-e063-6294a90a7cce2024-10-16WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
application number: M013
Low dose Chewable AspirinASPIRINFSA STORE INC.f939b44c-93b6-ca61-e053-6394a90ae5862024-10-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINDISCOUNT DRUG MARTaf0f50d2-3e2d-f723-e053-2995a90a0d4b2024-10-16WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINDISCOUNT DRUG MART03ed19dd-1cfc-47d5-b83e-ffa2ebe93f482024-10-16WarningsExact identifier
application number: M013
PAIN RELIEF Regular StrengthACETAMINOPHENAMERICAN SALES COMPANY2e3eabc8-193b-4397-a43c-db838eb16e672024-10-15WarningsExact identifier
application number: M013
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact 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 TabletPSN0c09a178-1a07-4079-b4a6-d1657cb8e7147
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD0c09a178-1a07-4079-b4a6-d1657cb8e7147
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY0c09a178-1a07-4079-b4a6-d1657cb8e7147

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70264-012-017026400120150 POUCH in 1 CARTON (70264-012-01) / 2 TABLET in 1 POUCH50 pouch2014-10-020000-00-00NoNoCurrent