Motrin IB

Product NDC: 73097-028
11-digit product format: 730970028
Labeler code: 73097
Product ID: 73097-028_56846774-8414-c306-e063-6394a90a2be8
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: 2026-01-01
Substance: IBUPROFEN
Active strength: 200 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 · 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.

Additional Listing Data#

Finished product: Yes
Brand name base: Motrin IB
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
201126	Internal RxNorm lookup
310965	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
56846774-8413-c306-e063-6394a90a2be8	Available on FDA.report

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 ndc (product): 73097-028
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73097-028-02	73097002802	1 POUCH in 1 CARTON (73097-028-02) / 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2026-01-01	No	No	Current
73097-028-40	73097002840	20 POUCH in 1 CARTON (73097-028-40) / 2 TABLET, FILM COATED in 1 POUCH	20 pouch	2026-01-01	No	No	Current
73097-028-50	73097002850	25 POUCH in 1 CARTON (73097-028-50) / 2 TABLET, FILM COATED in 1 POUCH	25 pouch	2026-01-01	No	No	Current