FDA.reportPublic FDA data

Acetaminophen and Ibuprofen

Product NDC
51316-132
11-digit product format
513160132
Labeler code
51316
Product ID
51316-132_46547b4f-b369-f246-e063-6394a90a3200
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
CVS
Application
ANDA216592
Marketing category
ANDA
Marketing start
2023-10-06
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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2387532

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
51316-132-72Acetaminophen and Ibuprofen72 in 1 BOTTLETABLET727
51316-132-81Acetaminophen and Ibuprofen18 in 1 BOTTLETABLET187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-132ACETAMINOPHEN AND IBUPROFEN TABLET [CVS]5Current NDC, 2 package rows20250504_f0d3f0ab-07ee-f068-e053-2995a90a481a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNf0d3f0ab-07ee-f068-e053-2995a90a481a7
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDf0d3f0ab-07ee-f068-e053-2995a90a481a7
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYf0d3f0ab-07ee-f068-e053-2995a90a481a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-132-725131601327272 TABLET in 1 BOTTLE (51316-132-72) 72 tablet2023-10-06NoNoCurrent
51316-132-815131601328118 TABLET in 1 BOTTLE (51316-132-81) 18 tablet2023-10-06NoNoCurrent