Application 022113

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADVIL ALLERGY AND CONGESTION RELIEF	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	TABLET;ORAL	4MG;200MG;10MG	Yes	Yes
002	ADVIL MULTI-SYMPTOM COLD & FLU	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	TABLET;ORAL	4MG;200MG;10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	4MG;200MG;10MG	TABLET / ORAL		RLD, RS	2011-12-21
N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	4MG;200MG;10MG	TABLET / ORAL		RLD, RS	2017-04-28

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`3a93d1ddd44b…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Advil Multi-Symptom Cold and Flu	CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7671d104-3c5c-4f63-b6b1-6c91c22592f8	2025-10-03	Warnings	Exact identifier application applno (NDA): 022113 application number: NDA022113 ndc (product): 0573-0190
Advil Allergy and Congestion Relief	CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a6cc97d8-252a-4527-a470-6d9e356342fd	2025-04-09	Warnings	Exact identifier application applno (NDA): 022113 application number: NDA022113 ndc (product): 0573-2161 ndc (product): 0573-0196
Advil Allergy and Congestion Relief	CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	d40bf078-ee6f-4c64-9c74-e4e770c150bf	2023-03-15	Warnings	Exact identifier application applno (NDA): 022113 application number: NDA022113 ndc (product): 67751-149

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-0190	Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0190	Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0190	Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0190	Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0190	Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0190	Advil Multi-Symptom Cold and Flu	chlorpheniramine maleate, ibuprofen, phenylephrine HCl	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0196	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	Pfizer Consumer Healthcare	NDA	Current
0573-2161	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2161	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	Wyeth Consumer Healthcare LLC	NDA	Current
0573-2161	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2161	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2161	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2161	Advil Allergy and Congestion Relief	chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
67751-149	Advil Allergy and Congestion Relief	CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current
67751-149	Advil Allergy and Congestion Relief	CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69425	SUPPL	2021-11-30
69409	SUPPL	2021-11-24
59954	SUPPL	2019-09-10
59953	SUPPL	2019-09-10
59303	SUPPL	2019-07-10
59299	SUPPL	2019-07-10
57524	SUPPL	2019-02-13
57453	SUPPL	2019-02-06
53018	SUPPL	2018-03-15
53017	SUPPL	2018-03-15
52782	SUPPL	2018-03-01
52781	SUPPL	2018-03-01
48213	SUPPL	2017-05-02
48171	SUPPL	2017-05-01
44682	ORIG	2012-09-06
42419	ORIG	2012-09-06
6912	ORIG	2011-12-28