Motrin IB

Product NDC: 73097-008
11-digit product format: 730970008
Labeler code: 73097
Product ID: 73097-008_8d6fe4a5-e7ba-3ccd-e053-2a95a90a346c
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Savings Distributors LLC
Application: NDA019012
Marketing category: NDA
Marketing start: 2019-07-05
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	73097-008		I	Inactivated by FDA	2026-10-05
excluded package	package	73097-008	73097-008-02	I	Inactivated by FDA	2026-10-05
excluded package	package	73097-008	73097-008-40	I	Inactivated by FDA	2026-10-05
excluded package	package	73097-008	73097-008-50	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 76 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-008-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-008-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-008-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-008-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-008-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-008-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-008-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-008-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-008-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-008-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-008-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-008-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-008-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-008-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-008-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-008-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-008-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-008-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-008-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-008-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-008-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-008-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-008-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-008-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-008-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-008-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-008-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-008-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-008-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-008-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-008-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-008-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-008-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-008-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-008-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-008-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-008-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-008-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-008-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-008-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-008-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-008-40	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-008-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-008-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-008-40	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019012-001	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1984-05-18
N019012-002	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1987-07-29
N019012-003	MOTRIN IB	IBUPROFEN	200MG	TABLET / ORAL	RLD	1990-12-17
N019012-004	MOTRIN MIGRAINE PAIN	IBUPROFEN	200MG	TABLET / ORAL		2000-02-25

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73097-008-02	2021-01-29	C162847	48780-1	ba0f9c33-1dae-a910-e053-dadaa90a0b85	Motrin IB
73097-008-40	2021-01-29	C162847	48780-1	ba0f9c33-1dae-a910-e053-dadaa90a0b85	Motrin IB
73097-008-50	2021-01-29	C162847	48780-1	ba0f9c33-1dae-a910-e053-dadaa90a0b85	Motrin IB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73097-008-02	Motrin IB	1 in 1 CARTON	TABLET, FILM COATED	1	1
73097-008-02	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	1
73097-008-40	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	1
73097-008-40	Motrin IB	20 in 1 CARTON	TABLET, FILM COATED	20	1
73097-008-50	Motrin IB	25 in 1 CARTON	TABLET, FILM COATED	25	1
73097-008-50	Motrin IB	2 in 1 POUCH	TABLET, FILM COATED	2	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73097-008	MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC]	1	Legacy NDC, 6 package rows	20190713_8d6fe91b-49d1-1af2-e053-2995a90a1777.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motrin IB	IBUPROFEN	Savings Distributors LLC	56846774-8413-c306-e063-6394a90a2be8	2026-01-01	Warnings	Exact identifier application applno (NDA): 019012 application number: NDA019012
Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	f70c1b68-61c8-b333-e053-6294a90aadaa	2023-03-16	Warnings	Exact identifier application applno (NDA): 019012 application number: NDA019012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	8d6fe91b-49d1-1af2-e053-2995a90a1777	1
201126	Motrin IB 200 MG Oral Tablet	PSN	8d6fe91b-49d1-1af2-e053-2995a90a1777	1
201126	ibuprofen 200 MG Oral Tablet [Motrin]	SBD	8d6fe91b-49d1-1af2-e053-2995a90a1777	1
310965	ibuprofen 200 MG Oral Tablet	SCD	8d6fe91b-49d1-1af2-e053-2995a90a1777	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	8d6fe91b-49d1-1af2-e053-2995a90a1777	1
201126	Motrin 200 MG Oral Tablet	SY	8d6fe91b-49d1-1af2-e053-2995a90a1777	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
73097-008-02	73097000802	1 in 1 CARTON	Historical
73097-008-40	73097000840	2 in 1 POUCH	Historical
73097-008-50	73097000850	25 in 1 CARTON	Historical