FDA.reportPublic FDA data

Advil Allergy and Congestion Relief

Product NDC
0573-0196
11-digit product format
005730196
Labeler code
0573
Product ID
0573-0196_ac233de1-41cf-4ef0-a7b4-30f395c88c1a
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA022113
Marketing category
NDA
Marketing start
2012-07-23
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

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 Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, V1Q0O9OJ9Z, WK2XYI10QM
Rxcui1310503

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0196-012024-01-31C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-022024-01-31C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-102024-01-31C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-202024-01-31C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-012024-01-30C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-022024-01-30C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-102024-01-30C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts
0573-0196-202024-01-30C16284748780-11030e364-fc70-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0196-01Advil Allergy and Congestion Relief50 in 1 TRAYTABLET, COATED5026
0573-0196-01Advil Allergy and Congestion Relief1 in 1 PACKETTABLET, COATED126
0573-0196-02Advil Allergy and Congestion Relief1 in 1 PACKETTABLET, COATED126
0573-0196-02Advil Allergy and Congestion Relief2 in 1 CARTONTABLET, COATED226
0573-0196-10Advil Allergy and Congestion Relief10 in 1 BLISTER PACKTABLET, COATED1026
0573-0196-10Advil Allergy and Congestion Relief1 in 1 CARTONTABLET, COATED126
0573-0196-20Advil Allergy and Congestion Relief10 in 1 BLISTER PACKTABLET, COATED1026
0573-0196-20Advil Allergy and Congestion Relief2 in 1 CARTONTABLET, COATED226

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0196-01EA - Each0573-01969d14018e-d877-4eef-85c7-31c9376c8d9812016-05-16
0573-0196-10EA - Each0573-0196fd9744d0-f04f-434a-804a-bda9e470cfe012013-02-13
0573-0196-20EA - Each0573-0196cc6b0675-9eef-4bbb-b743-6c202410d3f012016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
TALCINACTIVE INGREDIENT7SEV7J4R1UADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
TRIACETININACTIVE INGREDIENTXHX3C3X673ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0196ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]26Current NDC, Legacy NDC, 8 package rows20250410_a6cc97d8-252a-4527-a470-6d9e356342fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSNa6cc97d8-252a-4527-a470-6d9e356342fd26
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDa6cc97d8-252a-4527-a470-6d9e356342fd26
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
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN883fcccb-cc1b-4b31-9649-771264546b131
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD883fcccb-cc1b-4b31-9649-771264546b131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0196-010057301960150 PACKET in 1 TRAY (0573-0196-01) / 1 TABLET, COATED in 1 PACKET50 packet2012-07-230000-00-00NoNoCurrent
0573-0196-02005730196022 PACKET in 1 CARTON (0573-0196-02) / 1 TABLET, COATED in 1 PACKET2 packet2019-10-010000-00-00NoNoCurrent
0573-0196-10005730196101 BLISTER PACK in 1 CARTON (0573-0196-10) / 10 TABLET, COATED in 1 BLISTER PACK1 blister pack2012-07-230000-00-00NoNoCurrent
0573-0196-20005730196202 BLISTER PACK in 1 CARTON (0573-0196-20) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2012-07-230000-00-00NoNoCurrent