Motrin

Product NDC: 50580-198
Requested package NDC: 50580-198-05
11-digit product format: 505800198
Labeler code: 50580
Product ID: 50580-198_519a1a5f-e816-0d56-e063-6294a90a337d
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION/ DROPS
Route: ORAL
Labeler: Kenvue Brands LLC
Application: NDA020603
Marketing category: NDA
Marketing start: 2001-09-01
Substance: IBUPROFEN
Active strength: 50 mg/1.25mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020603-001	CHILDREN'S MOTRIN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL		RLD, RS	1996-06-10

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.

Product history page 1 of 2 · 43 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	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020603-001	CHILDREN'S MOTRIN	40MG/ML	SUSPENSION/DROPS / ORAL	RLD, RS	1996-06-10	`f41ea6bd6efb…`

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
Brand name suffix: Infants
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	50 mg/1.25mL

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
204442	Internal RxNorm lookup
854762	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
c57f6ded-c0bd-45ae-823a-4c02ce334d98	Available on FDA.report

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
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 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

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

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
Infants Motrin	IBUPROFEN	Kenvue Brands LLC	c2302bfe-b367-4867-b803-29f066a42dc7	2026-06-30	Warnings	Exact identifier application applno (NDA): 020603 application number: NDA020603
Motrin Infants	IBUPROFEN	Kenvue Brands LLC	c57f6ded-c0bd-45ae-823a-4c02ce334d98	2026-05-12	Warnings	Exact identifier application applno (NDA): 020603 application number: NDA020603 ndc (package): 50580-198-05 ndc (product): 50580-198 ndc11 (package): 50580019805

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
204442	ibuprofen 50 MG in 1.25 mL Oral Suspension	PSN	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
854762	Motrin Infant Drops Concentrated 50 MG in 1.25 mL Oral Suspension	PSN	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
854762	ibuprofen 40 MG/ML Oral Suspension [Motrin]	SBD	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
204442	ibuprofen 40 MG/ML Oral Suspension	SCD	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
204442	ibuprofen 50 MG per 1.25 ML Oral Suspension	SY	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
204442	ibuprofen 50 MG per 1.25 ML Oral Suspension Drops	SY	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
854762	Infants' Motrin 40 MG/ML Oral Suspension	SY	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
854762	Motrin 40 MG/ML Oral Suspension	SY	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17
854762	Motrin Infant Drops 50 MG per 1.25 ML Oral Suspension	SY	c57f6ded-c0bd-45ae-823a-4c02ce334d98	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50580-198-05	50580019805	1 BOTTLE in 1 CARTON (50580-198-05) / 15 mL in 1 BOTTLE	1 bottle	2026-06-08	No	No	Current