Ibuprofen

Product NDC: 55319-046
Requested package NDC: 55319-046-16
11-digit product format: 553190046
Labeler code: 55319
Product ID: 55319-046_6403a89b-ae4d-42e5-9a5c-d51613f0f42a
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: ANDA207753
Marketing category: ANDA
Marketing start: 2020-06-30
Marketing end: 2025-06-30
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	55319-046	55319-046-16	D	Discontinued by firm		2026-08-11

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207753-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-06-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55319-046-16	2022-10-31	DRUG FACTS
55319-046-20	2022-10-31	DRUG FACTS
55319-046-16	2022-01-28	DRUG FACTS
55319-046-20	2022-01-28	DRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-046	IBUPROFEN CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]	2	Legacy NDC	20221101_ff13ff8f-ef17-4d08-bd44-058a080c8c61.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Aurohealth LLC	43c94480-78d1-4a23-91d4-1d49fea72cb7	2026-06-05	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	P & L Development, LLC	ce215099-91b0-43fd-8ac9-17fe6508842c	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	da9d0301-ec14-40c5-b0b9-17096913a849	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Better Living Brands LLC	f6ef7f73-b5ab-4c82-e053-6394a90ac81e	2023-09-22	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	RITE AID CORPORATION	de158883-1175-18fc-e053-2995a90a3c96	2023-04-12	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	e1b49257-d226-457f-8f2d-9a757a65bbcb	2022-09-06	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	3b0e77a1-b49d-4c67-81dd-66450dabcf3b	2022-03-04	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-046-16	55319004616	160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55319-046-16)	2020-06-30	2025-06-30	No	No	Current