FDA.reportPublic FDA data

Acetaminophen 250 mg and Ibuprofen 125 mg

Product NDC
70264-040
11-digit product format
702640040
Labeler code
70264
Product ID
70264-040_43c8f4e2-0cd4-448f-e063-6394a90a3a88
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 250 mg and Ibuprofen 125 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
R J General Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-30
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
250; 125 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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
Acetaminophen 250 mg and Ibuprofen 125 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
IBUPROFEN125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387532Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
68d3be55-9340-4cc9-a05a-12b9338ddc56Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-040-12Acetaminophen 250 mg and Ibuprofen 125 mg50 in 1 CARTONTABLET, FILM COATED502
70264-040-12Acetaminophen 250 mg and Ibuprofen 125 mg2 in 1 POUCHTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-040ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLET, FILM COATED [R J GENERAL CORPORATION]1Current NDC, 2 package rows20241116_68d3be55-9340-4cc9-a05a-12b9338ddc56.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 28 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTH, TRAVEL BASIXACETAMINOPHENLil' Drug Store Products, Inc.fa951d50-b79c-4161-8c81-fcf386b0964e2025-12-15WarningsExact identifier
application number: M013
Vanquish Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEDSE Healthcare Solutions, LLCcbf12223-ef44-494b-9d3c-971dce3c5ade2025-12-15WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8bc75bcf-01c9-41d0-a96f-77a24e3edf012025-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS40a1b354-9b2e-1cf3-e063-6394a90af1132025-12-13WarningsExact identifier
application number: M013
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
application number: M013
Pain Reliever, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN TABLETLil' Drug Store Products, Inc.45c397bd-a1ff-1246-e063-6394a90ac54a2025-12-12WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c7c11b-d627-aee8-e063-6294a90a401d2025-12-12WarningsExact identifier
application number: M013
AspirinASPIRINTOP CARE (Topco Associates LLC)d3df90be-9037-44b2-bf48-540d68a033b22025-12-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINHy-Vee98ab6fb7-c7e5-45ab-97c3-81d422f8a8432025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma33599f18-5f49-4f22-8a77-a072115763ef2025-12-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINVALU MERCHANDISERS COMPANY746059b3-ed18-4a81-a70e-4d758e048d8e2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY005e299e-aa84-49d9-bbca-12236f865a272025-12-11WarningsExact identifier
application number: M013
Low Dose Chewable AspirinASPIRINVALU MERCHANDISERS COMPANY7d88f156-d361-4249-b70d-4bbcd5ba30b72025-12-11WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINVALU MERCHANDISERS COMPANYcc18e8e1-652e-44da-a9d7-e56cebda55a12025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYd4c32e70-778a-4d66-b9d0-03944a5284212025-12-11WarningsExact identifier
application number: M013
adult low dose aspirinASPIRINVALU MERCHANDISERS COMPANY6fa1c707-bd42-455b-90a3-2c2a11acc6832025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY5a80cb17-7731-4457-acd3-64cf4accf8622025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENVALU MERCHANDISERS COMPANY02e3798f-86d9-64b4-e063-6294a90a29de2025-12-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN68d3be55-9340-4cc9-a05a-12b9338ddc562
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD68d3be55-9340-4cc9-a05a-12b9338ddc562
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY68d3be55-9340-4cc9-a05a-12b9338ddc562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70264-040-127026400401250 POUCH in 1 CARTON (70264-040-12) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2024-10-30NoNoCurrent