Advil Multi-Symptom Cold and Flu

Product NDC
0573-0190
Requested package NDC
0573-0190-20
11-digit product format
005730190
Labeler code
0573
Product ID
0573-0190_4042cf07-a239-1ae9-e063-6394a90acd01
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, ibuprofen, phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA022113
Marketing category
NDA
Marketing start
2018-06-25
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 Multi-Symptom Cold and Flu
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
7671d104-3c5c-4f63-b6b1-6c91c22592f8Available on FDA.report

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0190-01Advil Multi-Symptom Cold and Flu1 in 1 POUCHTABLET, COATED114
0573-0190-01Advil Multi-Symptom Cold and Flu50 in 1 TRAYTABLET, COATED5014
0573-0190-02Advil Multi-Symptom Cold and Flu2 in 1 CARTONTABLET, COATED214
0573-0190-02Advil Multi-Symptom Cold and Flu1 in 1 POUCHTABLET, COATED114
0573-0190-03Advil Multi-Symptom Cold and Flu1 in 1 POUCHTABLET, COATED114
0573-0190-03Advil Multi-Symptom Cold and Flu3000 in 1 CASETABLET, COATED300014
0573-0190-10Advil Multi-Symptom Cold and Flu1 in 1 CARTONTABLET, COATED114
0573-0190-10Advil Multi-Symptom Cold and Flu10 in 1 BLISTER PACKTABLET, COATED1014
0573-0190-20Advil Multi-Symptom Cold and Flu2 in 1 CARTONTABLET, COATED214
0573-0190-20Advil Multi-Symptom Cold and Flu10 in 1 BLISTER PACKTABLET, COATED1014
0573-0190-30Advil Multi-Symptom Cold and Flu10 in 1 BLISTER PACKTABLET, COATED1014
0573-0190-30Advil Multi-Symptom Cold and Flu3 in 1 CARTONTABLET, COATED314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0190-01EA - Each0573-019039b9c0f2-4011-4ec7-bde8-3375d2810b3b12022-06-06
0573-0190-10EA - Each0573-0190d6a5ce79-edd1-49f2-be81-9652fc874f6112020-07-13
0573-0190-20EA - Each0573-01903de50adc-b436-4fb7-8162-9c6d7968000212020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0190ADVIL MULTI-SYMPTOM COLD AND FLU (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HCL) TABLET, COATED [HALEON US HOLDINGS LLC]12Current NDC, Legacy NDC, 12 package rows20250410_7671d104-3c5c-4f63-b6b1-6c91c22592f8.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
ndc (package): 0573-0190-20
ndc (product): 0573-0190
ndc11 (package): 00573019020
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN7671d104-3c5c-4f63-b6b1-6c91c22592f814
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD7671d104-3c5c-4f63-b6b1-6c91c22592f814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0190-20005730190202 BLISTER PACK in 1 CARTON (0573-0190-20) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-06-250000-00-00NoNoCurrent