FDA.reportPublic FDA data

Acetaminophen and Ibuprofen

Product NDC
51316-131
11-digit product format
513160131
Labeler code
51316
Product ID
51316-131_46545016-29d2-7e81-e063-6294a90a941f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
CVS
Application
ANDA216592
Marketing category
ANDA
Marketing start
2023-10-01
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
51316-131-36Acetaminophen and Ibuprofen36 in 1 BOTTLETABLET367
51316-131-44Acetaminophen and Ibuprofen144 in 1 BOTTLETABLET1447
51316-131-72Acetaminophen and Ibuprofen72 in 1 BOTTLETABLET727

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-131ACETAMINOPHEN AND IBUPROFEN TABLET [CVS]5Current NDC, 3 package rows20250504_e45830a0-c884-e556-e053-2995a90ab565.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNe45830a0-c884-e556-e053-2995a90ab5657
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDe45830a0-c884-e556-e053-2995a90ab5657
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYe45830a0-c884-e556-e053-2995a90ab5657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-131-365131601313636 TABLET in 1 BOTTLE (51316-131-36) 36 tablet2023-10-01NoNoHistorical
51316-131-4451316013144144 TABLET in 1 BOTTLE (51316-131-44) 144 tablet2023-10-01NoNoHistorical
51316-131-725131601317272 TABLET in 1 BOTTLE (51316-131-72) 72 tablet2023-10-01NoNoHistorical