ADVIL

Product NDC: 29485-6500
11-digit product format: 294856500
Labeler code: 29485
Product ID: 29485-6500_f2175fae-9ac7-f8c1-e053-2995a90affbd
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN Tablet coated
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Mechanical Servants LLC
Application: NDA018989
Marketing category: NDA
Marketing start: 2017-08-17
Marketing end: 0000-00-00
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: 2024-12-31
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	29485-6500		D	Discontinued by firm		2026-08-10
excluded package	package	29485-6500	29485-6500-4	D	Discontinued by firm		2026-08-10

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
N018989-001	ADVIL	IBUPROFEN	200MG	TABLET / ORAL		RLD, RS	1984-05-18

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-6500	ADVIL (IBUPROFEN TABLET COATED) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	9	Legacy NDC	20231207_d09ddb5a-465b-519f-e053-2995a90a16d5.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL	IBUPROFEN	Select Consumer Group	3ca752d8-957c-21b4-e063-6294a90a5285	2026-07-03	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	Navajo Manufacturing Company Inc.	4a64522f-b7d8-47f7-bf07-c9e8f1086425	2026-04-08	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
ADVIL	IBUPROFEN	Haleon US Holdings LLC	1a665e64-9f30-be37-4a83-38789f1f1e89	2026-03-12	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	JC World Bell Wholesale Co., Inc.	0b83c9ed-3630-4c5c-9020-cf38183a6500	2025-06-27	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	Lil' Drug Store Products, Inc.	772360bd-8631-4d24-b4db-5a7e6e1d9a13	2025-01-27	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN TABLETS, COATED	Lil' Drug Store Products, Inc.	dd302e18-39e9-7e1a-e053-2a95a90a5f7c	2024-07-17	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989

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
29485-6500-4	29485650004	2 POUCH in 1 BLISTER PACK (29485-6500-4) > 2 TABLET, COATED in 1 POUCH	2 pouch	2017-08-17	0000-00-00	No	No	Current