Advil Allergy and Congestion Relief

Product NDC
67751-149
Requested package NDC
67751-149-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022113-001ADVIL ALLERGY AND CONGESTION RELIEFCHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21
N022113-002ADVIL MULTI-SYMPTOM COLD & FLUCHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21782e0a99824c…
2021-12-28 21:50 UTC2021-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Advil Allergy and Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
IBUPROFEN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
WK2XYI10QMInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1310503Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d40bf078-ee6f-4c64-9c74-e4e770c150bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-149-01Advil Allergy and Congestion Relief1 in 1 CARTONTABLET, COATED14
67751-149-01Advil Allergy and Congestion Relief1 in 1 POUCHTABLET, COATED14
67751-149-02Advil Allergy and Congestion Relief2 in 1 CARTONTABLET, COATED24
67751-149-02Advil Allergy and Congestion Relief1 in 1 POUCHTABLET, COATED14
67751-149-03Advil Allergy and Congestion Relief12 in 1 TRAYTABLET, COATED124
67751-149-03Advil Allergy and Congestion Relief1 in 1 POUCHTABLET, COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-149ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]4Current NDC, Legacy NDC, 6 package rows20230316_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advil Multi-Symptom Cold and FluCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HCLHaleon US Holdings LLC7671d104-3c5c-4f63-b6b1-6c91c22592f82025-10-03WarningsExact identifier
application applno (NDA): 022113
application number: NDA022113
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa6cc97d8-252a-4527-a470-6d9e356342fd2025-04-09WarningsExact identifier
application applno (NDA): 022113
application number: NDA022113
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.d40bf078-ee6f-4c64-9c74-e4e770c150bf2023-03-15WarningsExact identifier
application applno (NDA): 022113
application number: NDA022113
ndc (package): 67751-149-01
ndc (product): 67751-149
ndc11 (package): 67751014901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSNd40bf078-ee6f-4c64-9c74-e4e770c150bf4
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDd40bf078-ee6f-4c64-9c74-e4e770c150bf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-149-01677510149011 POUCH in 1 CARTON (67751-149-01) / 1 TABLET, COATED in 1 POUCH1 pouch2016-09-160000-00-00NoNoCurrent