Dual Action

Product NDC: 41226-716
11-digit product format: 412260716
Labeler code: 41226
Product ID: 41226-716_002fdf94-eba4-9115-e063-6294a90a1582
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: KROGER COMPANY
Application: ANDA216994
Marketing category: ANDA
Marketing start: 2023-07-11
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216994-001	ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET / ORAL			2023-07-10

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
2026-02-19 14:30 UTC	2026-02	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216994-001	ACETAMINOPHEN AND IBUPROFEN	250MG;125MG	TABLET / ORAL	2023-07-10	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dual Action
Listing expiration: 2026-12-31

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
ee0ae5e6-388d-0085-e053-2a95a90add8e	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
41226-716-49	Dual Action	144 in 1 BOTTLE	TABLET	144		2
41226-716-49	Dual Action	1 in 1 CARTON	TABLET	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-716	DUAL ACTION (ACETAMINOPHEN, IBUPROFEN) TABLET [KROGER COMPANY]	2	Current NDC, 2 package rows	20230712_ee0ae5e6-388d-0085-e053-2a95a90add8e.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen 250 mg and Ibuprofen 125 mg	ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS	MARKSANS PHARMA LIMITED	46121a30-1361-4f2b-9f3f-3cedabd66c33	2025-12-12	Warnings	Exact identifier application applno (ANDA): 216994 application number: ANDA216994
Dual Action Pain Relief	ACETAMINOPHEN, IBUPROFEN	TARGET CORPORATION	e680652b-30d8-6009-e053-2995a90abe29	2024-09-25	Warnings	Exact identifier application applno (ANDA): 216994 application number: ANDA216994
Dual Action	ACETAMINOPHEN, IBUPROFEN	BETTER LIVING BRANDS, LLC	f2c096bb-cfed-bfa4-e053-2995a90af2cb	2024-08-22	Warnings	Exact identifier application applno (ANDA): 216994 application number: ANDA216994
Dual Action Pain Relief	ACETAMINOPHEN, IBUPROFEN	TIME CAP LABORATORIES, INC.	08acd3bf-ad0c-f693-e063-6394a90ad8c2	2023-10-27	Warnings	Exact identifier application applno (ANDA): 216994 application number: ANDA216994
Dual Action	ACETAMINOPHEN, IBUPROFEN	KROGER COMPANY	ee0ae5e6-388d-0085-e053-2a95a90add8e	2023-07-12	Warnings	Exact identifier application applno (ANDA): 216994 application number: ANDA216994 ndc (product): 41226-716

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	ee0ae5e6-388d-0085-e053-2a95a90add8e	2
2387532	acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet	SCD	ee0ae5e6-388d-0085-e053-2a95a90add8e	2
2387532	APAP 250 MG / ibuprofen 125 MG Oral Tablet	SY	ee0ae5e6-388d-0085-e053-2a95a90add8e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
41226-716-49	41226071649	1 BOTTLE in 1 CARTON (41226-716-49) / 144 TABLET in 1 BOTTLE	1 bottle	2023-07-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
716R Kroger 41226-716 Acetaminophen and Ibuprofen Tablets 250 mg/ 125 mg	KROGER COMPANY \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2023-07-12	HUMAN OTC DRUG LABEL	2