IBUPROFEN

Product NDC: 72036-211
11-digit product format: 720360211
Labeler code: 72036
Product ID: 72036-211_57c17222-de16-8407-e063-6394a90a5aee
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Harris Teeter
Application: ANDA202312
Marketing category: ANDA
Marketing start: 2019-12-13
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: 2027-12-31
Current FDA listing: Yes

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
A202312-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2016-10-07

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	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: IBUPROFEN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310965	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
14515409-736f-4119-b6a0-cb19ee2e948e	Available on FDA.report

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
72036-211-02	Ibuprofen	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	3
72036-211-02	Ibuprofen	1 in 1 CARTON	TABLET, COATED	1	3
72036-211-03	Ibuprofen	1 in 1 CARTON	TABLET, COATED	1	3
72036-211-03	Ibuprofen	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72036-211	IBUPROFEN TABLET, COATED [HARRIS TEETER]	3	Current NDC, Legacy NDC, 4 package rows	20250523_14515409-736f-4119-b6a0-cb19ee2e948e.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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fecb3a8-d288-cacf-e053-2a95a90ae238	2025-07-01	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fed1f86-49a0-4747-e053-2a95a90a42b8	2025-07-01	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	78cf5df8-392b-4a4e-b424-af765a6defdf	2025-06-17	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	a60a6301-60b7-4f31-9ebe-872ccd8e9e76	2025-05-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	32f86bfb-67a6-49b5-a90a-5197f0d1baba	2025-05-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART	9998b851-825b-a97d-e053-2a95a90affc6	2025-05-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART	999902da-4850-68ab-e053-2a95a90a82ea	2025-05-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Assured Ibuprofen	IBUPROFEN	Spirit Pharmaceuticals LLC	119263b5-c3b7-46dc-a3bd-9893bfd24628	2024-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	a3fadcc0-97f5-9f9b-e053-2a95a90aeb54	2023-03-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	cef74c2f-0c23-609d-e053-2a95a90a6b8e	2022-11-23	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen IB	IBUPROFEN	WINCO FOODS, LLC	9d78644d-83c7-46d1-8156-0d76acb7c299	2020-09-17	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen IB	IBUPROFEN	WINCO FOODS, LLC	ee867519-227f-44ba-ba8b-2dbefcc9fc67	2020-09-17	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen 200mg	IBUPROFEN 200MG	Athlete's Needs, Inc.	2db10105-6fd3-420d-8889-7cfd6f396e5f	2017-11-14	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312

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
310965	ibuprofen 200 MG Oral Tablet	PSN	14515409-736f-4119-b6a0-cb19ee2e948e	3
310965	ibuprofen 200 MG Oral Tablet	SCD	14515409-736f-4119-b6a0-cb19ee2e948e	3
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	14515409-736f-4119-b6a0-cb19ee2e948e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72036-211-02	72036021102	1 BOTTLE, PLASTIC in 1 CARTON (72036-211-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2019-12-13	0000-00-00	No	No	Current
72036-211-03	72036021103	1 BOTTLE, PLASTIC in 1 CARTON (72036-211-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2019-12-13	0000-00-00	No	No	Current