Good Sense Dual Action Back Pain

Product NDC
0113-5299
11-digit product format
001135299
Labeler code
0113
Product ID
0113-5299_89476188-cf88-4184-a366-ed4c2e7db145
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA214836
Marketing category
ANDA
Marketing start
2024-03-07
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214836-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense Dual Action Back Pain
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2387532Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89476188-cf88-4184-a366-ed4c2e7db145Available on FDA.report

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
0113-5299-16Good Sense Dual Action Back Pain144 in 1 BOTTLETABLET, FILM COATED1441
0113-5299-16Good Sense Dual Action Back Pain1 in 1 CARTONTABLET, FILM COATED11
0113-5299-23Good Sense Dual Action Back Pain1 in 1 CARTONTABLET, FILM COATED11
0113-5299-23Good Sense Dual Action Back Pain72 in 1 BOTTLETABLET, FILM COATED721
0113-5299-68Good Sense Dual Action Back Pain1 in 1 CARTONTABLET, FILM COATED11
0113-5299-68Good Sense Dual Action Back Pain36 in 1 BOTTLETABLET, FILM COATED361
0113-5299-89Good Sense Dual Action Back Pain1 in 1 CARTONTABLET, FILM COATED11
0113-5299-89Good Sense Dual Action Back Pain18 in 1 BOTTLETABLET, FILM COATED181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-5299GOOD SENSE DUAL ACTION BACK PAIN (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [L. PERRIGO COMPANY]1Current NDC, 8 package rows20240322_89476188-cf88-4184-a366-ed4c2e7db145.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dual actionACETAMINOPHEN, IBUPROFENPublix Super Markets Ince185d119-3484-40b1-afb8-6dca49d45e402026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dual pain relieverACETAMINOPHEN, IBUPROFENMeijer, Inc.db1dc4f6-23ec-4a04-baa8-ffa739bce76a2026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
DUAL ACTIONACETAMINOPHEN, IBUPROFENAmazon.com Services LLC20fe6b3f-e5a6-47d4-a371-9172408fbc462026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
acetaminophen and ibuprofenACETAMINOPHEN, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
topcare dual actionACETAMINOPHEN, IBUPROFENTopco Associates LLCdddc04c4-d500-4d42-8406-89f27a9ad6512026-06-04WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
DUAL ACTION BACK PAIN RELIEVERACETAMINOPHEN, IBUPROFENMeijer, Inc.8d9a0c56-ef22-45a6-8b1d-d2b2f32472102026-03-19WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
DUAL ACTIONACETAMINOPHEN, IBUPROFENHyVee Inc9cec2952-6f40-4352-8ffd-b46988b7df312026-03-18WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
good sense dual actionACETAMINOPHEN, IBUPROFENSportpharm LLC3f4ade2c-56e0-4aab-910e-73c26546a4d72026-02-06WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Motrin Dual Action With TylenolACETAMINOPHEN AND IBUPROFENKenvue Brands LLCf2ee9cf5-02b7-6612-e053-2995a90a90c42026-02-03WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
equate dual pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.09dc976b-6065-4aad-9d57-0fe5e88a722a2025-12-15WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702025-11-03WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2025-09-30WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
CAREONE DUAL ACTIONACETAMINOPHEN, IBUPROFENRetail Business Services, LLC76302cb3-0371-49ce-85d8-5f3785c370b02025-08-25WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2025-08-08WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dg health dual back pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Incb52cfead-1cff-4e11-9953-f470fb785c732025-07-07WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2025-06-05WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
equate dual back pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.af7e6478-177f-473d-9d14-1e78610b1a6e2025-05-17WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2024-11-20WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2024-03-25WarningsExact identifier
application applno (ANDA): 214836
application number: ANDA214836

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN89476188-cf88-4184-a366-ed4c2e7db1451
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD89476188-cf88-4184-a366-ed4c2e7db1451
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY89476188-cf88-4184-a366-ed4c2e7db1451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-5299-16001135299161 BOTTLE in 1 CARTON (0113-5299-16) / 144 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-15NoNoCurrent
0113-5299-23001135299231 BOTTLE in 1 CARTON (0113-5299-23) / 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-07NoNoCurrent
0113-5299-68001135299681 BOTTLE in 1 CARTON (0113-5299-68) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-07NoNoCurrent
0113-5299-89001135299891 BOTTLE in 1 CARTON (0113-5299-89) / 18 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-15NoNoCurrent