Ibuprofen

Product NDC: 81522-938
11-digit product format: 815220938
Labeler code: 81522
Product ID: 81522-938_4d5620e3-33b4-411a-9b19-561762e312f5
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: FSA Store Inc. (Caring Mills)
Application: ANDA074916
Marketing category: ANDA
Marketing start: 2022-04-15
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	81522-938		D	Discontinued by firm		2026-11-13
excluded package	package	81522-938	81522-938-04	D	Discontinued by firm		2026-11-13

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A074916-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1999-04-30

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	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074916-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1999-04-30	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81522-938-04	IbuprofenChildrens	118 mL in 1 BOTTLE	SUSPENSION	118		2
81522-938-04	IbuprofenChildrens	1 in 1 CARTON	SUSPENSION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-938	IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [FSA STORE INC. (CARING MILLS)]	1	Legacy NDC, 2 package rows	20220430_e304f791-755d-4d11-a9f6-3d46ec84197f.zip

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
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	e304f791-755d-4d11-a9f6-3d46ec84197f	2
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	e304f791-755d-4d11-a9f6-3d46ec84197f	2
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	e304f791-755d-4d11-a9f6-3d46ec84197f	2
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	e304f791-755d-4d11-a9f6-3d46ec84197f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-938-04	81522093804	1 BOTTLE in 1 CARTON (81522-938-04) > 118 mL in 1 BOTTLE	1 bottle	2022-04-15	0000-00-00	No	No	Current