FDA.reportPublic FDA data

equate dual back pain reliever

Product NDC
79903-326
11-digit product format
799030326
Labeler code
79903
Product ID
79903-326_f77edac2-7f2e-4835-b9e4-f759729b8939
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WALMART INC.
Application
ANDA214836
Marketing category
ANDA
Marketing start
2025-05-03
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
equate dual back 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
79903-326-72equate dual back pain reliever72 in 1 BOTTLETABLET, FILM COATED722
79903-326-72equate dual back pain reliever1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-326EQUATE DUAL BACK PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [WALMART INC.]2Current NDC, 2 package rows20250522_af7e6478-177f-473d-9d14-1e78610b1a6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNaf7e6478-177f-473d-9d14-1e78610b1a6e2
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDaf7e6478-177f-473d-9d14-1e78610b1a6e2
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYaf7e6478-177f-473d-9d14-1e78610b1a6e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-326-72799030326721 BOTTLE in 1 CARTON (79903-326-72) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-05-03NoNoCurrent