ADVIL PM

Product NDC: 0573-0164
11-digit product format: 005730164
Labeler code: 0573
Product ID: 0573-0164_15971707-84cd-4742-e063-6394a90af906
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine citrate and ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: NDA021394
Marketing category: NDA
Marketing start: 2005-12-21
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38; 200 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0573-0164		D	Discontinued by firm		2026-10-05
excluded package	package	0573-0164	0573-0164-34	D	Discontinued by firm		2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-0164-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-0164-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-0164-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-0164-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-0164-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-0164-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-0164-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-0164-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-0164-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-0164-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0573-0164-34	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0573-0164-34	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021394-001	ADVIL PM	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL		RLD, RS	2005-12-21

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021394-001	8263647	2022-05-30	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021394-001	8263647	2022-05-30	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021394-001	8263647	2022-05-30	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021394-001	8263647	2022-05-30	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021394-001	8263647	2022-05-30	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021394-001	8263647	2022-05-30	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021394-001	8263647	2022-05-30	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021394-001	8263647	2022-05-30	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021394-001	8263647	2022-05-30	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021394-001	8263647	2022-05-30	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021394-001	8263647	2022-05-30	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021394-001	8263647	2022-05-30	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021394-001	8263647	2022-05-30	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021394-001	8263647	2022-05-30	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021394-001	8263647	2022-05-30	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021394-001	8263647	2022-05-30	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021394-001	8263647	2022-05-30	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021394-001	8263647	2022-05-30	Drug product	`cb3db0bc1861…`

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: ADVIL PM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE CITRATE	38 mg/1
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4OD433S209	Internal UNII lookup
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
895664	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
658fc201-47c9-6a6d-8af9-6208298d43b4	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
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
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
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	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
0573-0164-04	Drug Facts
0573-0164-05	Drug Facts
0573-0164-08	Drug Facts
0573-0164-09	Drug Facts
0573-0164-12	Drug Facts
0573-0164-14	Drug Facts
0573-0164-20	Drug Facts
0573-0164-21	Drug Facts
0573-0164-30	Drug Facts
0573-0164-32	Drug Facts
0573-0164-33	Drug Facts
0573-0164-40	Drug Facts
0573-0164-41	Drug Facts
0573-0164-43	Drug Facts
0573-0164-44	Drug Facts
0573-0164-45	Drug Facts
0573-0164-46	Drug Facts
0573-0164-49	Drug Facts
0573-0164-55	Drug Facts
0573-0164-65	Drug Facts
0573-0164-91	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-0164-04	ADVIL PM	4 in 1 POUCH	TABLET, COATED	4	21
0573-0164-05	ADVIL PM	2 in 1 BOTTLE	TABLET, COATED	2	21
0573-0164-05	ADVIL PM	2 in 1 CARTON	TABLET, COATED	2	21
0573-0164-08	ADVIL PM	8 in 1 VIAL	TABLET, COATED	8	21
0573-0164-08	ADVIL PM	1 in 1 PACKAGE	TABLET, COATED	1	21
0573-0164-09	ADVIL PM	8 in 1 VIAL	TABLET, COATED	8	21
0573-0164-12	ADVIL PM	2 in 1 POUCH	TABLET, COATED	2	21
0573-0164-12	ADVIL PM	6 in 1 CARTON	TABLET, COATED	6	21
0573-0164-14	ADVIL PM	2 in 1 POUCH	TABLET, COATED	2	21
0573-0164-14	ADVIL PM	2 in 1 CARTON	TABLET, COATED	2	21
0573-0164-20	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-20	ADVIL PM	20 in 1 BOTTLE	TABLET, COATED	20	21
0573-0164-21	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-21	ADVIL PM	30 in 1 BOTTLE	TABLET, COATED	30	21
0573-0164-30	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-30	ADVIL PM	40 in 1 BOTTLE	TABLET, COATED	40	21
0573-0164-32	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-32	ADVIL PM	50 in 1 BOTTLE	TABLET, COATED	50	21
0573-0164-33	ADVIL PM	50 in 1 BOTTLE	TABLET, COATED	50	21
0573-0164-33	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-40	ADVIL PM	80 in 1 BOTTLE	TABLET, COATED	80	21
0573-0164-40	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-41	ADVIL PM	100 in 1 BOTTLE	TABLET, COATED	100	21
0573-0164-41	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-43	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-43	ADVIL PM	120 in 1 BOTTLE	TABLET, COATED	120	21
0573-0164-44	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-44	ADVIL PM	140 in 1 BOTTLE	TABLET, COATED	140	21
0573-0164-45	ADVIL PM	180 in 1 BOTTLE	TABLET, COATED	180	21
0573-0164-45	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-46	ADVIL PM	180 in 1 BOTTLE	TABLET, COATED	180	21
0573-0164-46	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-49	ADVIL PM	1 in 1 CARTON	TABLET, COATED	1	21
0573-0164-49	ADVIL PM	200 in 1 BOTTLE	TABLET, COATED	200	21
0573-0164-55	ADVIL PM	50 in 1 TRAY	TABLET, COATED	50	21
0573-0164-55	ADVIL PM	2 in 1 POUCH	TABLET, COATED	2	21
0573-0164-65	ADVIL PM	120 in 1 BOTTLE	TABLET, COATED	120	21
0573-0164-91	ADVIL PM	3000 in 1 BOX	TABLET, COATED	3000	21
0573-0164-91	ADVIL PM	2 in 1 POUCH	TABLET, COATED	2	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0164-05	EA - Each	0573-0164	29ee0873-ce1d-488b-945e-8060bb4ccb4a	1	2012-07-24
0573-0164-08	EA - Each	0573-0164	61da8eca-12fa-4e21-ad47-a371b3e87f99	1	2022-06-06
0573-0164-12	EA - Each	0573-0164	17b84eac-a74d-4ffe-8ac8-3de75c13d8e0	1	2019-06-19
0573-0164-14	EA - Each	0573-0164	f1a6b8ef-c28d-4a6d-9a89-98d4e5372015	1	2019-06-19
0573-0164-20	EA - Each	0573-0164	e0975540-d483-4aa3-9a5f-a647f2986fcc	1	2012-07-24
0573-0164-30	EA - Each	0573-0164	da7bb72a-9d06-4eb0-b919-d87393627420	1	2012-07-24
0573-0164-40	EA - Each	0573-0164	ad944255-4b0d-4ec7-9f86-47f47e6b9d91	1	2012-07-24
0573-0164-43	EA - Each	0573-0164	40258c9f-9173-4c4c-95de-258d67f51a5f	1	2013-08-02
0573-0164-55	EA - Each	0573-0164	88938333-f8b2-4a98-8627-645de71706b2	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE CITRATE	ACTIVE INGREDIENT	4OD433S209	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-0164	ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [HALEON US HOLDINGS LLC]	21	Current NDC, Legacy NDC, 39 package rows	20240410_658fc201-47c9-6a6d-8af9-6208298d43b4.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Select Consumer Group	52c67ae0-707c-851b-e063-6294a90afda4	2026-05-27	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
Advil PM	DIPHENHYDRAMINE CITRATE, IBUPROFEN	Navajo Manufacturing Company Inc.	a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7	2026-04-08	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	ADVIL PM	Lil Drug Store Products, Inc	d1138e15-8ae4-7b49-e053-2995a90a9607	2024-12-30	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
Advil PM, TRAVEL BASIX	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Lil' Drug Store Products, Inc.	b876bb40-a38b-445a-bc8a-466b3bfe166d	2024-11-27	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394
ADVIL PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Haleon US Holdings LLC	658fc201-47c9-6a6d-8af9-6208298d43b4	2024-04-08	Warnings	Exact identifier application applno (NDA): 021394 application number: NDA021394 ndc (product): 0573-0164

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4OD433S209	DIPHENHYDRAMINE CITRATE	88637-37-0	DIPHENHYDRAMINE CITRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
895664	ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	658fc201-47c9-6a6d-8af9-6208298d43b4	21
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	658fc201-47c9-6a6d-8af9-6208298d43b4	21
895664	ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7	3
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-0164-04	00573016404	4 TABLET, COATED in 1 POUCH (0573-0164-04)		2005-12-21	0000-00-00	No	No	Current
0573-0164-05	00573016405	2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE	2 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-08	00573016408	1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL	1 vial	2017-03-17	0000-00-00	No	No	Current
0573-0164-09	00573016409	8 TABLET, COATED in 1 VIAL (0573-0164-09)		2017-03-17	0000-00-00	No	No	Current
0573-0164-12	00573016412	6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH	6 pouch	2005-12-21	0000-00-00	No	No	Current
0573-0164-14	00573016414	2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH	2 pouch	2005-12-21	0000-00-00	No	No	Current
0573-0164-20	00573016420	1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-21	00573016421	1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-30	00573016430	1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-32	00573016432	1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-33	00573016433	1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-40	00573016440	1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-41	00573016441	1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-43	00573016443	1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-44	00573016444	1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-45	00573016445	1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-46	00573016446	1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-49	00573016449	1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE	1 bottle	2005-12-21	0000-00-00	No	No	Current
0573-0164-55	00573016455	50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH	50 pouch	2005-12-21	0000-00-00	No	No	Current
0573-0164-65	00573016465	120 TABLET, COATED in 1 BOTTLE (0573-0164-65)		2016-09-30	0000-00-00	No	No	Current
0573-0164-91	00573016491	3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH	3000 pouch	2005-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Select Consumer Group \| Select Consumer Group LLC	2026-05-27	HUMAN OTC DRUG LABEL	1
Advil PM	Navajo Manufacturing Company Inc.	2026-04-08	HUMAN OTC DRUG LABEL	3
Drug Facts	Haleon US Holdings LLC	2024-04-08	HUMAN OTC DRUG LABEL	21
98 Excellence Way	WYETH CONSUMER HEALTHCARE LLC \| Exel Inc. dba DHL Supply Chain (USA)	2018-11-20	HUMAN OTC DRUG LABEL	2