Advil Sinus Congestion and Pain

Product NDC: 52904-782
11-digit product format: 529040782
Labeler code: 52904
Product ID: 52904-782_bf8fc6fa-d880-4cd1-a815-1d3ad3cd955e
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen, phenylephrine hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Select Corporation
Application: NDA022565
Marketing category: NDA
Marketing start: 2015-07-01
Marketing end: 0000-00-00
Substance: IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 200 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52904-782		I	Inactivated by FDA	2026-10-02
excluded package	package	52904-782	52904-782-03	I	Inactivated by FDA	2026-10-02
excluded package	package	52904-782	52904-782-04	I	Inactivated by FDA	2026-10-02
excluded package	package	52904-782	52904-782-25	I	Inactivated by FDA	2026-10-02
excluded package	package	52904-782	52904-782-50	I	Inactivated by FDA	2026-10-02

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 2 · 75 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	52904-782-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-782-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-782-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-782-25	`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	52904-782-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-782-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-782-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-782-25	`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	52904-782-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-782-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-782-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-782-25	`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	52904-782-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-782-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-782-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-782-25	`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	52904-782-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-782-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-782-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-782-25	`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	52904-782-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-782-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-782-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-782-25	`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	52904-782-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-782-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-782-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-782-25	`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	52904-782-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-782-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-782-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-782-25	`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	52904-782-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-782-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-782-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-782-25	`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	52904-782-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-782-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-782-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-782-25	`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	52904-782-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-782-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-782-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-782-25	`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	52904-782-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-782-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-782-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-782-25	`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
N022565-001	ADVIL CONGESTION RELIEF	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET / ORAL		RLD, RS	2010-05-27

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	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`f41ea6bd6efb…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52904-782-03	Advil ® Sinus Congestion & Pain
52904-782-04	Advil ® Sinus Congestion & Pain
52904-782-25	Advil ® Sinus Congestion & Pain
52904-782-50	Advil ® Sinus Congestion & Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52904-782-03	Advil Sinus Congestion and Pain	1 in 1 BLISTER PACK	TABLET, COATED	1	2
52904-782-03	Advil Sinus Congestion and Pain	1 in 1 POUCH	TABLET, COATED	1	2
52904-782-04	Advil Sinus Congestion and Pain	2 in 1 BLISTER PACK	TABLET, COATED	2	2
52904-782-04	Advil Sinus Congestion and Pain	1 in 1 POUCH	TABLET, COATED	1	2
52904-782-25	Advil Sinus Congestion and Pain	25 in 1 CARTON	TABLET, COATED	25	2
52904-782-25	Advil Sinus Congestion and Pain	1 in 1 POUCH	TABLET, COATED	1	2
52904-782-50	Advil Sinus Congestion and Pain	1 in 1 POUCH	TABLET, COATED	1	2
52904-782-50	Advil Sinus Congestion and Pain	50 in 1 CARTON	TABLET, COATED	50	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52904-782	ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SELECT CORPORATION]	2	Legacy NDC, 8 package rows	20220414_dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL SINUS CONGESTION AND PAIN	IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf	2025-07-22	Warnings	Exact identifier application applno (NDA): 022565 application number: NDA022565
Advil Sinus Congestion and Pain Relief	IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	531abadc-37fd-4953-95bc-a211a2ba6914	2023-03-15	Warnings	Exact identifier application applno (NDA): 022565 application number: NDA022565

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1369775	ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9	2
1369775	ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52904-782-03	52904078203	1 POUCH in 1 BLISTER PACK (52904-782-03) > 1 TABLET, COATED in 1 POUCH	1 pouch	2015-07-01	0000-00-00	No	No	Current
52904-782-04	52904078204	2 POUCH in 1 BLISTER PACK (52904-782-04) > 1 TABLET, COATED in 1 POUCH	2 pouch	2015-07-01	0000-00-00	No	No	Current
52904-782-25	52904078225	25 POUCH in 1 CARTON (52904-782-25) > 1 TABLET, COATED in 1 POUCH	25 pouch	2015-07-01	0000-00-00	No	No	Current
52904-782-50	52904078250	50 POUCH in 1 CARTON (52904-782-50) > 1 TABLET, COATED in 1 POUCH	50 pouch	2015-07-01	0000-00-00	No	No	Current