ADVIL

Product NDC: 0573-0165
11-digit product format: 005730165
Labeler code: 0573
Product ID: 0573-0165_4cd840a6-9554-de58-e063-6394a90ab543
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: NDA018989
Marketing category: NDA
Marketing start: 1984-05-18
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ADVIL
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
153008	Internal RxNorm lookup
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
1a665e64-9f30-be37-4a83-38789f1f1e89	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
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0573-0165-20	Drug Facts
0573-0165-25	Drug Facts
0573-0165-30	Drug Facts
0573-0165-31	Drug Facts
0573-0165-40	Drug Facts
0573-0165-41	Drug Facts
0573-0165-42	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-0165-20	ADVIL	24 in 1 BOTTLE	TABLET, COATED	24	38
0573-0165-20	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-25	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-25	ADVIL	36 in 1 BOTTLE	TABLET, COATED	36	38
0573-0165-30	ADVIL	50 in 1 BOTTLE	TABLET, COATED	50	38
0573-0165-30	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-31	ADVIL	75 in 1 BOTTLE	TABLET, COATED	75	38
0573-0165-31	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-40	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-40	ADVIL	100 in 1 BOTTLE	TABLET, COATED	100	38
0573-0165-41	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-41	ADVIL	125 in 1 BOTTLE	TABLET, COATED	125	38
0573-0165-42	ADVIL	1 in 1 CARTON	TABLET, COATED	1	38
0573-0165-42	ADVIL	150 in 1 BOTTLE	TABLET, COATED	150	38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0165-20	EA - Each	0573-0165	2585176f-2f45-44c9-8502-d8bf60d7ccb2	1	2012-07-24
0573-0165-30	EA - Each	0573-0165	e29ec965-043e-4691-8b89-dbce027e94b5	1	2012-07-24
0573-0165-40	EA - Each	0573-0165	6fb53bdf-3beb-43bb-b308-d5c495d4c44b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
DIACETYLATED MONOGLYCERIDES	INACTIVE INGREDIENT	5Z17386USF	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	ADVIL (IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-0165	ADVIL (IBUPROFEN) TABLET, COATED [HALEON US HOLDINGS LLC]	36	Current NDC, Legacy NDC, 14 package rows	20240410_1a665e64-9f30-be37-4a83-38789f1f1e89.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 ndc (product): 0573-0165
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
153008	Advil 200 MG Oral Tablet	PSN	1a665e64-9f30-be37-4a83-38789f1f1e89	38
310965	ibuprofen 200 MG Oral Tablet	PSN	1a665e64-9f30-be37-4a83-38789f1f1e89	38
153008	ibuprofen 200 MG Oral Tablet [Advil]	SBD	1a665e64-9f30-be37-4a83-38789f1f1e89	38
310965	ibuprofen 200 MG Oral Tablet	SCD	1a665e64-9f30-be37-4a83-38789f1f1e89	38
153008	Advil 200 MG Oral Tablet	SY	1a665e64-9f30-be37-4a83-38789f1f1e89	38
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	1a665e64-9f30-be37-4a83-38789f1f1e89	38

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-0165-20	00573016520	1 BOTTLE in 1 CARTON (0573-0165-20) / 24 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current
0573-0165-25	00573016525	1 BOTTLE in 1 CARTON (0573-0165-25) / 36 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current
0573-0165-30	00573016530	1 BOTTLE in 1 CARTON (0573-0165-30) / 50 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current
0573-0165-31	00573016531	1 BOTTLE in 1 CARTON (0573-0165-31) / 75 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current
0573-0165-40	00573016540	1 BOTTLE in 1 CARTON (0573-0165-40) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current
0573-0165-41	00573016541	1 BOTTLE in 1 CARTON (0573-0165-41) / 125 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current
0573-0165-42	00573016542	1 BOTTLE in 1 CARTON (0573-0165-42) / 150 TABLET, COATED in 1 BOTTLE	1 bottle	1984-05-18	0000-00-00	No	No	Current