FDA.reportPublic FDA data

dg health dual back pain reliever

Product NDC
55910-508
11-digit product format
559100508
Labeler code
55910
Product ID
55910-508_83981f7c-bbb0-4912-b7ca-3f4a2418ffca
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA214836
Marketing category
ANDA
Marketing start
2024-04-26
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
dg health 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
55910-508-23dg health dual back pain reliever1 in 1 CARTONTABLET, FILM COATED12
55910-508-23dg health dual back pain reliever72 in 1 BOTTLETABLET, FILM COATED722
55910-508-68dg health dual back pain reliever1 in 1 CARTONTABLET, FILM COATED12
55910-508-68dg health dual back pain reliever36 in 1 BOTTLETABLET, FILM COATED362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-508DG HEALTH DUAL BACK PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [DOLGENCORP INC]1Current NDC, 4 package rows20240514_b52cfead-1cff-4e11-9953-f470fb785c73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNb52cfead-1cff-4e11-9953-f470fb785c732
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDb52cfead-1cff-4e11-9953-f470fb785c732
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYb52cfead-1cff-4e11-9953-f470fb785c732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-508-23559100508231 BOTTLE in 1 CARTON (55910-508-23) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-06-27NoNoCurrent
55910-508-68559100508681 BOTTLE in 1 CARTON (55910-508-68) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-04-26NoNoCurrent