WinCo Foods Childrens Ibuprofen

Product NDC: 67091-367
11-digit product format: 670910367
Labeler code: 67091
Product ID: 67091-367_56a33686-88ff-4c97-a8a3-e3ad2e7b05ea
Type: HUMAN OTC DRUG
Nonproprietary name: Childrens Ibuprofen Oral Suspension
Dosage form: SUSPENSION
Route: ORAL
Labeler: WinCo Foods, LLC
Application: ANDA210602
Marketing category: ANDA
Marketing start: 2020-09-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67091-367		D	Discontinued by firm		2026-10-12
excluded package	package	67091-367	67091-367-04	D	Discontinued by firm		2026-10-12

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67091-367-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67091-367-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67091-367-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67091-367-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67091-367-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67091-367-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67091-367-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67091-367-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67091-367-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67091-367-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67091-367-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67091-367-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67091-367-04	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67091-367-04	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67091-367-04	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A210602-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2018-11-23

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210602-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-11-23	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67091-367-04	2022-12-16	C162847	48780-1	d6a99b39-47dc-a426-e053-dadaa90af4c2	Children's Ibuprofen Oral Suspension (NSAID)
67091-367-04	2022-01-28	C162847	48780-1	d6a99b39-47dc-a426-e053-dadaa90af4c2	Children's Ibuprofen Oral Suspension (NSAID)

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	6dc47070-4185-404f-94b0-5252a78ea6fe	2024-01-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	e4e778f3-97f9-4fd7-8eb8-9ceb5bc9ee7d	2024-01-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Bryant Ranch Prepack	3762ee9b-5811-46e2-83df-db5f6863e055	2024-01-18	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen Oral Suspension	IBUPROFEN	DEMOULAS SUPERMARKETS INC.	4ca54293-9e81-4b24-8112-734f28cd2c55	2023-12-29	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	A-S Medication Solutions	a8672e5a-61f2-46d8-9401-432a978d2fd3	2023-12-15	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Childrens Ibuprofen	IBUPROFEN	American Health Packaging	bc69d88b-d9af-4010-8e8f-e761a9e295a9	2023-12-05	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Pediacare Childrens Ibuprofen Berry	IBUPROFEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	347d081f-068c-4173-9b4b-001ab2b891f5	2022-12-20	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Ibuprofen Oral	IBUPROFEN ORAL	Strategic Sourcing Services	a3062142-db0e-4758-a762-2b2bb05670b1	2022-08-10	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602
Dolex Children	IBUPROFEN	Pharmadel LLC	ac3c264f-da37-a474-e053-2a95a90abdad	2020-08-06	Warnings	Exact identifier application applno (ANDA): 210602 application number: ANDA210602

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
67091-367-04	67091036704	1 BOTTLE in 1 CARTON (67091-367-04) > 118 mL in 1 BOTTLE	1 bottle	2020-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Ibuprofen Oral Suspension (NSAID)	WinCo Foods, LLC \| Aptapharma Inc.	2020-09-29	HUMAN OTC DRUG LABEL	1