FDA.reportPublic FDA data

acetaminophen and ibuprofen

Product NDC
30142-720
11-digit product format
301420720
Labeler code
30142
Product ID
30142-720_5e73e32a-e091-4281-97ae-d98307c675ac
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
ANDA214836
Marketing category
ANDA
Marketing start
2023-05-16
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
2027-12-31

Active Ingredients#

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

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
30142-720-23acetaminophen and ibuprofen1 in 1 CARTONTABLET, FILM COATED13
30142-720-23acetaminophen and ibuprofen72 in 1 BOTTLETABLET, FILM COATED723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-720ACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [KROGER COMPANY]2Current NDC, 2 package rows20230608_e6c0cca6-812e-4bea-86b0-e15b10f3f0d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNe6c0cca6-812e-4bea-86b0-e15b10f3f0d43
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDe6c0cca6-812e-4bea-86b0-e15b10f3f0d43
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYe6c0cca6-812e-4bea-86b0-e15b10f3f0d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30142-720-23301420720231 BOTTLE in 1 CARTON (30142-720-23) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-16NoNoHistorical