DUAL ACTION BACK PAIN RELIEVER

Product NDC: 79481-0152
11-digit product format: 794810152
Labeler code: 79481
Product ID: 79481-0152_76a6eefa-8ec6-4a1a-8aac-9fbd227e5a4d
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Meijer, Inc.
Application: ANDA214836
Marketing category: ANDA
Marketing start: 2026-03-05
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214836-001	ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET / ORAL			2023-02-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214836-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-02-28	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: DUAL ACTION BACK PAIN RELIEVER
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	250 mg/1
IBUPROFEN	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d9a0c56-ef22-45a6-8b1d-d2b2f3247210	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79481-0152-0	DUAL ACTION BACK PAIN RELIEVER	1 in 1 CARTON	TABLET, FILM COATED	1		2
79481-0152-1	DUAL ACTION BACK PAIN RELIEVER	72 in 1 BOTTLE	TABLET, FILM COATED	72		2

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate dual back pain reliever	ACETAMINOPHEN, IBUPROFEN	WALMART INC.	af7e6478-177f-473d-9d14-1e78610b1a6e	2025-05-17	Warnings	Exact identifier application applno (ANDA): 214836 application number: ANDA214836
Good Sense Dual Action Back Pain	ACETAMINOPHEN, IBUPROFEN	L. Perrigo Company	89476188-cf88-4184-a366-ed4c2e7db145	2024-03-19	Warnings	Exact identifier application applno (ANDA): 214836 application number: ANDA214836
Basic Care Dual Action	ACETAMINOPHEN, IBUPROFEN	Amazon.com Services LLC	7e27f5cb-8728-400f-82c5-0984276aa5dd	2024-02-20	Warnings	Exact identifier application applno (ANDA): 214836 application number: ANDA214836
Topcare Dual Action Back Pain	ACETAMINOPHEN, IBUPROFEN	Topco Associates LLC	e40ec21c-6c44-4219-a94f-8b93a4853aa5	2024-02-06	Warnings	Exact identifier application applno (ANDA): 214836 application number: ANDA214836
DG health dual pain reliever	ACETAMINOPHEN, IBUPROFEN	Dolgencorp Inc	464d436a-79b0-45b4-8b5f-51dc2de2d8e4	2023-05-19	Warnings	Exact identifier application applno (ANDA): 214836 application number: ANDA214836
equate pain reliever	ACETAMINOPHEN, IBUPROFEN	WALMART INC.	8e0aaae0-a97d-4b9d-b326-44ef45f3fa0c	2023-03-17	Warnings	Exact identifier application applno (ANDA): 214836 application number: ANDA214836

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2387532	acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet	PSN	8d9a0c56-ef22-45a6-8b1d-d2b2f3247210	2
2387532	acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet	SCD	8d9a0c56-ef22-45a6-8b1d-d2b2f3247210	2
2387532	APAP 250 MG / ibuprofen 125 MG Oral Tablet	SY	8d9a0c56-ef22-45a6-8b1d-d2b2f3247210	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
79481-0152-0	79481015200	1 BOTTLE in 1 CARTON (79481-0152-0) / 72 TABLET, FILM COATED in 1 BOTTLE (79481-0152-1)	1 bottle	2026-03-05	No	No	Current
79481-0152-1	79481015201	72 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Dual Action Back Pain Reliever Drug Facts	Meijer, Inc.	2026-03-19	HUMAN OTC DRUG LABEL	2