Dual Action Pain Relief

Product NDC: 49483-716
11-digit product format: 494830716
Labeler code: 49483
Product ID: 49483-716_08acd3bf-ad0d-f693-e063-6394a90ad8c2
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC.
Application: ANDA216994
Marketing category: ANDA
Marketing start: 2023-10-13
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 Pain Relief
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
08acd3bf-ad0c-f693-e063-6394a90ad8c2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-716-49	Dual Action Pain Relief	144 in 1 BOTTLE	TABLET	144	1
49483-716-49	Dual Action Pain Relief	1 in 1 CARTON	TABLET	1	1
49483-716-75	Dual Action Pain Relief	1 in 1 CARTON	TABLET	1	1
49483-716-75	Dual Action Pain Relief	72 in 1 BOTTLE	TABLET	72	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-716	DUAL ACTION PAIN RELIEF (ACETAMINOPHEN, IBUPROFEN) TABLET [TIME CAP LABORATORIES, INC.]	1	Current NDC, 4 package rows	20231027_08acd3bf-ad0c-f693-e063-6394a90ad8c2.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 ndc (product): 49483-716
Dual Action	ACETAMINOPHEN, IBUPROFEN	KROGER COMPANY	ee0ae5e6-388d-0085-e053-2a95a90add8e	2023-07-12	Warnings	Exact identifier application applno (ANDA): 216994 application number: ANDA216994

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	08acd3bf-ad0c-f693-e063-6394a90ad8c2	1
2387532	acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet	SCD	08acd3bf-ad0c-f693-e063-6394a90ad8c2	1
2387532	APAP 250 MG / ibuprofen 125 MG Oral Tablet	SY	08acd3bf-ad0c-f693-e063-6394a90ad8c2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49483-716-49	49483071649	1 BOTTLE in 1 CARTON (49483-716-49) / 144 TABLET in 1 BOTTLE	1 bottle	2023-10-13	No	No	Current
49483-716-75	49483071675	1 BOTTLE in 1 CARTON (49483-716-75) / 72 TABLET in 1 BOTTLE	1 bottle	2023-10-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
716R Albertsons 21130-716 Acetaminophen and Ibuprofen Tablets 250 mg/ 125 mg	TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2023-10-27	HUMAN OTC DRUG LABEL	1