FDA.reportPublic FDA data

equaline dual action pain reliever

Product NDC
41163-103
11-digit product format
411630103
Labeler code
41163
Product ID
41163-103_4348c154-9502-40c5-84d1-816ccd1ac90f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA214836
Marketing category
ANDA
Marketing start
2024-03-21
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
equaline dual action 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
41163-103-68equaline dual action pain reliever1 in 1 CARTONTABLET, FILM COATED12
41163-103-68equaline dual action pain reliever36 in 1 BOTTLETABLET, FILM COATED362
41163-103-89equaline dual action pain reliever1 in 1 CARTONTABLET, FILM COATED12
41163-103-89equaline dual action pain reliever18 in 1 BOTTLETABLET, FILM COATED182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-103EQUALINE DUAL ACTION PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]2Current NDC, 4 package rows20240413_ae0dc3f1-ee6f-4347-af5d-70f45dd68bdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41163-103-68411630103681 BOTTLE in 1 CARTON (41163-103-68) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-21NoNoHistorical
41163-103-89411630103891 BOTTLE in 1 CARTON (41163-103-89) / 18 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-21NoNoHistorical