Harris Teeter Childrens Ibuprofen

Product NDC: 69256-660
11-digit product format: 692560660
Labeler code: 69256
Product ID: 69256-660_24bf2ca4-e4fa-41dc-82ab-f31b4ab9840c
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Harris Teeter, LLC
Application: ANDA074937
Marketing category: ANDA
Marketing start: 2015-11-21
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	69256-660		D	Discontinued by firm		2026-10-05
excluded package	package	69256-660	69256-660-26	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69256-660-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69256-660-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69256-660-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69256-660-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69256-660-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69256-660-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69256-660-26	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69256-660-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69256-660-26	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69256-660-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69256-660-26	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69256-660-26	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A074937-001	CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1998-12-22

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 · 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	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	HARRIS TEETER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [HARRIS TEETER, LLC]	1

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 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense ibuprofen childrens	IBUPROFEN	Preferred Pharmaceuticals Inc.	7ac61180-d668-4eec-b04f-d14f7b552a4d	2025-12-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
topcare childrens ibuprofen	IBUPROFEN	Topco Associates LLC	d1bb68a6-3a29-4a4e-b4e9-413cc8d16191	2025-12-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a1a5a9c7-c727-4e41-a8f0-2982f796a3ca	2025-09-29	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	fbbc67a7-359f-4155-9367-3815c05ccf03	2025-08-08	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	59b881f9-1830-4bce-99d2-9770c9b2575f	2025-08-08	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Safeway	0fe94b11-f7c9-4e32-976f-e5f11d01bd64	2025-07-09	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	009dde4c-d944-4206-8c9f-35bc8fd92715	2025-06-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen Childrens	IBUPROFEN	Kroger Company	47a3b118-614d-405d-b80e-31f0b354c430	2025-06-25	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	40a6a842-a85b-4e24-8786-32ecd74f6870	2025-06-25	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Safeway	1b7854d6-32b9-4410-bb40-0f02e46c7966	2025-06-24	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
care one ibuprofen childrens	IBUPROFEN	American Sales Company	c56511fd-ff2e-40f6-91e6-fe04e563fafd	2025-06-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
profen IB childrens	IBUPROFEN	Publix Super Markets Inc	1af04e26-e32c-4c1c-bbda-2c78f2030ac6	2025-06-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Topcare Childrens Ibuprofen	IBUPROFEN	Topco Associates LLC	45255d2f-c592-4750-abb5-21647d4fbd51	2025-06-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	Meijer Distribution Inc	625226ef-d55b-4f93-ad1e-4fe2b07d4133	2025-06-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	9eafb61a-43bc-4845-b45a-72c7d5ac424e	2025-06-05	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Good Sense Ibuprofen Childrens	IBUPROFEN	L. Perrigo Company	321d6b3a-3dff-4334-b6ee-6ac801b9907c	2025-06-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Leader Childrens Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	2b0c3bb1-7667-403f-99e6-13c83755b1b5	2025-06-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
up and up childrens ibuprofen	IBUPROFEN	Target Corporation	834b7f5e-e636-4537-9bae-2d309fcc8eb3	2025-06-02	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equate ibuprofen childrens	IBUPROFEN	Wal-Mart Stores Inc	ed9ee7b5-2d9a-4aaf-a245-aa13fcc6365a	2025-05-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	92878aad-0bf9-4303-a1f8-4b9b23848a71	2025-05-21	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937

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
69256-660-26	69256066026	1 BOTTLE in 1 CARTON (69256-660-26) > 120 mL in 1 BOTTLE	1 bottle	2015-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Harris Teeter, LLC Children’s Ibuprofen Oral Suspension Drug Facts	Harris Teeter, LLC	2018-02-15	HUMAN OTC DRUG LABEL	3