NDC 55289-590-16 - Ibuprofen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 55289-590
Requested NDC: 55289-590-16
Package NDCs from labels: 55289-590-08, 55289-590-10, 55289-590-12, 55289-590-15, 55289-590-20, 55289-590-21, 55289-590-30, 55289-590-36, 55289-590-40, 55289-590-60, 55289-590-90, 55289-590-93, 55289-590-16
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Effective date: 2019-06-06
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ibuprofen Tablets, USP (400 mg) Rx Only	PD-Rx Pharmaceuticals, Inc.	2019-06-06	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-590-08	EA - Each	55289-590	c6356cda-630e-4d7b-a43e-6e917ace5950	1	2012-07-24
55289-590-10	EA - Each	55289-590	9a3f88fe-d527-4f72-b3bb-90188dd66259	1	2012-07-24
55289-590-12	EA - Each	55289-590	0b64c33d-77e0-4d25-9758-c96c0a77712b	1	2012-07-24
55289-590-15	EA - Each	55289-590	ca4304d0-c3ef-45d1-be54-213c9042f9cc	1	2012-07-24
55289-590-16	EA - Each	55289-590	1b899dc0-4b4c-4cd9-b1af-20c8afcc1afc	1	2012-07-24
55289-590-20	EA - Each	55289-590	ea7f91db-c8d5-4c8d-ac8d-cb37dca6e91b	1	2012-07-24
55289-590-21	EA - Each	55289-590	9ef440bf-2e05-45f1-b8b6-70ab24c3776c	1	2012-07-24
55289-590-30	EA - Each	55289-590	50b72e93-9689-4dec-97f6-cd6e98d5c489	1	2012-07-24
55289-590-36	EA - Each	55289-590	958ec51f-f803-4a03-b0db-6cb17031bd62	1	2012-07-24
55289-590-40	EA - Each	55289-590	d4ee6509-cd72-4189-95e6-7960709191ea	1	2012-07-24
55289-590-60	EA - Each	55289-590	e1127b58-e18a-4ce3-8db3-22f7f12868de	1	2012-07-24
55289-590-90	EA - Each	55289-590	30e689f7-b293-4297-aa80-ab3a01534fae	1	2012-07-24
55289-590-93	EA - Each	55289-590	b72cdd28-8bf1-4d7c-ad82-b506a3cb58df	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5

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 57 · 1,138 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dual action	ACETAMINOPHEN, IBUPROFEN	Rite Aid Corporation	54b08d24-d5e9-4111-9d97-329896e8309d	2026-09-09	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Lidl US LLC	0ca02f8b-4413-4e7c-a67b-8c67c53e1343	2026-09-09	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	GOODSENSE	596a1007-08ea-00ec-e063-6394a90a5eb2	2026-09-09	Warnings	Exact identifier unii: WK2XYI10QM
ibuprofen childrens	IBUPROFEN	Rite Aid Corporation	c6e68886-edcb-414d-9cba-0d97772ef8b6	2026-09-09	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2144eff0-d7ab-486d-b116-a4ff3ae2afe2	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197806 unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	The Kroger Co.	a7789f7f-3356-463b-9fd7-2d7f7eba2799	2026-09-08	Warnings	Exact identifier unii: WK2XYI10QM
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	90659e83-d989-46a5-9680-3a4f61612511	2026-09-04	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Direct_Rx	40071818-5bf0-095b-e063-6294a90ad58a	2026-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197806 unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	8d518a08-486a-4d11-b042-27fc1e6060c9	2026-09-03	Warnings	Exact identifier unii: WK2XYI10QM
IBUPROFEN Immediate Release	IBUPROFEN	Strides Pharma Inc	a5dd275f-f388-44ec-8297-74430a742d52	2026-09-02	Boxed warning, Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0fa4cd66-66ad-4ec9-b38c-6b5840df39df	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197805 unii: WK2XYI10QM
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	2026-09-02	Boxed warning, Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	99730c4a-d2ee-46f5-91f4-a15cbaace40d	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197806 unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3a38add6-a114-4e18-836c-3bfc727db231	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197807 unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	404df13d-4ada-4324-9eed-e21f5d5043a4	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197807 unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	fef89d3f-16e1-4a76-aabd-11d6eca4be86	2026-09-01	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Gobrands, Inc. (Goodnow)	04e1b176-b74a-413e-a8e1-dd3764b9aa8b	2026-09-01	Warnings	Exact identifier unii: WK2XYI10QM
equaline dual action pain reliever	ACETAMINOPHEN, IBUPROFEN	United Natural Foods, Inc. dba UNFI	ae0dc3f1-ee6f-4347-af5d-70f45dd68bdb	2026-08-27	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2572ed69-d5a7-4513-a202-aca3230e7ec5	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197806 unii: WK2XYI10QM
foster and thrive dual action	ACETAMINOPHEN, IBUPROFEN	Strategic Sourcing Services LLC	f970d423-1d92-40c0-8358-91d1f963505c	2026-08-26	Warnings	Exact identifier unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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