Advil Allergy and Congestion Relief

Product NDC: 67751-149
Requested package NDC: 67751-149-03
11-digit product format: 677510149
Labeler code: 67751
Product ID: 67751-149_f6f71bb0-5bac-59f7-e053-6394a90abf8e
Type: HUMAN OTC DRUG
Nonproprietary name: CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Navajo Manufacturing Company Inc.
Application: NDA022113
Marketing category: NDA
Marketing start: 2016-09-16
Substance: CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 4; 200; 10 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67751-149	67751-149-03	D	Discontinued by firm		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 1 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 1 of 3 · 86 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	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`4b0b4de00fa7…`
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…`

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 Allergy and Congestion Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1
IBUPROFEN	200 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup
WK2XYI10QM	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1310503	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
d40bf078-ee6f-4c64-9c74-e4e770c150bf	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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
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
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67751-149-01	2023-03-15	Advil Allergy & Congestion Relief
67751-149-02	2023-03-15	Advil Allergy & Congestion Relief
67751-149-03	2023-03-15	Advil Allergy & Congestion Relief
67751-149-01	2023-01-30	Advil Allergy & Congestion Relief
67751-149-02	2023-01-30	Advil Allergy & Congestion Relief
67751-149-03	2023-01-30	Advil Allergy & Congestion Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-149-01	Advil Allergy and Congestion Relief	1 in 1 CARTON	TABLET, COATED	1	4
67751-149-01	Advil Allergy and Congestion Relief	1 in 1 POUCH	TABLET, COATED	1	4
67751-149-02	Advil Allergy and Congestion Relief	2 in 1 CARTON	TABLET, COATED	2	4
67751-149-02	Advil Allergy and Congestion Relief	1 in 1 POUCH	TABLET, COATED	1	4
67751-149-03	Advil Allergy and Congestion Relief	12 in 1 TRAY	TABLET, COATED	12	4
67751-149-03	Advil Allergy and Congestion Relief	1 in 1 POUCH	TABLET, COATED	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-149	ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]	4	Current NDC, Legacy NDC, 6 package rows	20230316_d40bf078-ee6f-4c64-9c74-e4e770c150bf.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 · 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
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
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 (package): 67751-149-03 ndc (product): 67751-149 ndc11 (package): 67751014903

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
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
1310503	chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	d40bf078-ee6f-4c64-9c74-e4e770c150bf	4
1310503	chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	d40bf078-ee6f-4c64-9c74-e4e770c150bf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-149-03	67751014903	12 POUCH in 1 TRAY (67751-149-03) > 1 TABLET, COATED in 1 POUCH	12 pouch	2016-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Advil Allergy & Congestion Relief	Navajo Manufacturing Company Inc.	2023-03-15	HUMAN OTC DRUG LABEL	4