FDA.reportPublic FDA data

dual pain reliever

Product NDC
0363-5220
11-digit product format
003635220
Labeler code
0363
Product ID
0363-5220_f64cb05e-be18-481e-894f-bdc0b8c2ef88
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA214836
Marketing category
ANDA
Marketing start
2023-03-10
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
dual pain reliever
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
0363-5220-01dual pain reliever216 in 1 BOTTLETABLET, FILM COATED2164
0363-5220-01dual pain reliever1 in 1 CARTONTABLET, FILM COATED14
0363-5220-16dual pain reliever144 in 1 BOTTLETABLET, FILM COATED1444
0363-5220-16dual pain reliever1 in 1 CARTONTABLET, FILM COATED14
0363-5220-23dual pain reliever1 in 1 CARTONTABLET, FILM COATED14
0363-5220-23dual pain reliever72 in 1 BOTTLETABLET, FILM COATED724
0363-5220-68dual pain reliever36 in 1 BOTTLETABLET, FILM COATED364
0363-5220-68dual pain reliever1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5220DUAL PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]3Current NDC, 8 package rows20240110_5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df4
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df4
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-5220-01003635220011 BOTTLE in 1 CARTON (0363-5220-01) / 216 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-12-11NoNoHistorical
0363-5220-16003635220161 BOTTLE in 1 CARTON (0363-5220-16) / 144 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-12-11NoNoHistorical
0363-5220-23003635220231 BOTTLE in 1 CARTON (0363-5220-23) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-10NoNoHistorical
0363-5220-68003635220681 BOTTLE in 1 CARTON (0363-5220-68) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-03-10NoNoHistorical