Childrens Novex Ibuprofen

Product NDC: 44237-041
Requested package NDC: 44237-041-02
11-digit product format: 442370041
Labeler code: 44237
Product ID: 44237-041_bdb2a2df-3d54-4c2a-a91f-4bd3545e11fa
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Herbion Pakistan (Pvt.) Ltd
Application: NDA020516
Marketing category: NDA
Marketing start: 2020-03-18
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	44237-041	44237-041-02	D	Discontinued by firm		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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020516-001	CHILDREN'S MOTRIN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		RLD, RS	1995-06-16
N020516-002	MOTRIN IB	IBUPROFEN	200MG/10ML	SUSPENSION / ORAL		RLD, RS	2026-07-22

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 · 45 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	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020516-002	MOTRIN IB	200MG/10ML	SUSPENSION / ORAL	RLD, RS	2026-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020516-002	MOTRIN IB	200MG/10ML	SUSPENSION / ORAL	RLD, RS	2026-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

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

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	4f664479-f68c-464a-956d-25bb9f39c4cc	2024-11-08	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	152189e5-391c-42d3-a03b-c8364e2de6bf	2024-11-08	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	9e1cdef7-921f-4163-869c-6c062e31c5bb	2024-11-01	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516
Childrens MOTRIN	IBUPROFEN	Kenvue Brands LLC	f2609308-17bf-4bcb-84b2-d17f3fd35958	2024-11-01	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516

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	Marketing end	Sample	Exclude flag	Status
44237-041-02	44237004102	1 BOTTLE in 1 CARTON (44237-041-02) > 120 mL in 1 BOTTLE	1 bottle	2020-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Novex Ibuprofen - Herbion Pakistan (Pvt.) Ltd	Herbion Pakistan (Pvt.) Ltd	2020-03-18	HUMAN OTC DRUG LABEL	1