NDC 50580-198-01 - Motrin Infants

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: 50580-198
Requested NDC: 50580-198-01
Package NDCs from labels: 50580-198-50, 50580-198-51, 50580-198-52, 50580-198-05, 50580-198-01
Manufacturer: Kenvue Brands LLC
Effective date: 2026-05-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Motrin Infants - Kenvue Brands LLC	Kenvue Brands LLC	2026-05-12	HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-11	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-198-50	2024-01-30	C162847	48780-1	1030e365-3a5b-111a-e063-dadaa90a10e2	Motrin ® Infants'
50580-198-51	2024-01-30	C162847	48780-1	1030e365-3a5b-111a-e063-dadaa90a10e2	Motrin ® Infants'
50580-198-52	2024-01-30	C162847	48780-1	1030e365-3a5b-111a-e063-dadaa90a10e2	Motrin ® Infants'

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-198-05	MotrinInfants	1 in 1 CARTON	SUSPENSION/ DROPS	1	17
50580-198-05	MotrinInfants	15 mL in 1 BOTTLE	SUSPENSION/ DROPS	15	17
50580-198-50	MotrinInfants	1 in 1 CARTON	SUSPENSION/ DROPS	1	17
50580-198-50	MotrinInfants	30 mL in 1 BOTTLE	SUSPENSION/ DROPS	30	17
50580-198-51	MotrinInfants	1 in 1 CARTON	SUSPENSION/ DROPS	1	17
50580-198-51	MotrinInfants	15 mL in 1 BOTTLE	SUSPENSION/ DROPS	15	17
50580-198-52	MotrinInfants	1 in 1 CARTON	SUSPENSION/ DROPS	1	17
50580-198-52	MotrinInfants	2 in 1 PACKAGE	SUSPENSION/ DROPS	2	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-198	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 8 package rows	20250124_c57f6ded-c0bd-45ae-823a-4c02ce334d98.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-198-01	ML - Milliliter	50580-198	d1eaf9e2-d545-46c8-9cc4-a48ea0d1e840	1	2013-02-11
50580-198-15	ML - Milliliter	50580-198	c0d5db24-6cad-4ad9-8a71-bdf15b809b24	1	2013-02-11
50580-198-50	ML - Milliliter	50580-198	6d73a606-d026-4d75-9745-635c94729bae	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
caramel	INACTIVE INGREDIENT	T9D99G2B1R	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
water	INACTIVE INGREDIENT	059QF0KO0R	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]	3

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 5 of 88 · 1,749 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DECONIMO Reconstitution	DECONIMO RECONSTITUTION	Image Amazon LLC	57ab9b1c-9a18-3786-e063-6394a90a2c63	2026-07-28	Warnings	Exact identifier unii: 059QF0KO0R
Ibuprofen and famotidine	IBUPROFEN AND FAMOTIDINE	Ascend Laboratories, LLC	4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	H E B	21567c0f-abba-4a40-a0b9-5ce49b3d9648	2026-07-28	Warnings	Exact identifier unii: WK2XYI10QM
Topwin Speedy Enema	GLYCERIN	Health Chemical Pharmaceutical Co., Ltd	3ba8c3d2-1780-42e1-bec5-8f98771d475e	2026-07-27	Warnings	Exact identifier unii: PDC6A3C0OX
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	656658cc-8cf0-42b6-af4f-4e3ab7648625	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	a7756b22-73cf-4262-aa8e-0577ddecd03b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	1ca722bb-940e-4b3e-9561-d87e2feb1ff8	2026-07-24	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	fc6c29b4-f1b3-4cfe-8c96-564d083be39c	2026-07-24	Warnings	Exact identifier unii: WK2XYI10QM
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	26bccfc1-bc8d-4241-a078-c760048951c9	2026-07-24	Warnings	Exact identifier unii: WK2XYI10QM
IBUPROFEN	IBUPROFEN	HF Acquisition Co LLC, DBA HealthFirst	574b6f15-70bc-fca7-e063-6294a90a0455	2026-07-23	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	Safeway, Inc.	a530d43d-e9c4-4edb-af66-c92860e46f45	2026-07-23	Warnings	Exact identifier unii: WK2XYI10QM
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier unii: PDC6A3C0OX unii: 6OZP39ZG8H
Ibuprofen	IBUPROFEN	TWIN MED LLC	f03958f8-aeae-edf0-e053-2a95a90a3e9e	2026-07-22	Warnings	Exact identifier unii: WK2XYI10QM
Xenleta	LEFAMULIN ACETATE	Meitheal Pharmaceuticals Inc.	eb972ea8-7502-422e-84bb-66cb8e93ca06	2026-07-22	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Good Sense ibuprofen	IBUPROFEN	L. Perrigo Company	aebae4b3-18c8-4ecf-b578-1fe7cc50076b	2026-07-22	Warnings	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	d3a7ebef-f7ab-4b34-b62e-278a8deabf78	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WK2XYI10QM
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WK2XYI10QM
Sterile Water	WATER	Cardinal Health 107, LLC	9655cd02-82b5-4a75-813b-854b19551481	2026-07-21	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WK2XYI10QM
Acetaminophen and Ibuprofen	ACETAMINOPHEN AND IBUPROFEN	CVS Pharmacy	52193849-d03a-b61b-e063-6394a90ad277	2026-07-20	Warnings	Exact identifier unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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