FDA.reportPublic FDA data

Advil Multi-Symptom Cold and Flu

Product NDC
0573-0190
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

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 Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, WK2XYI10QM, 04JA59TNSJ
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0190-012024-02-01C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-022024-02-01C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-032024-02-01C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-102024-02-01C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-202024-02-01C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-302024-02-01C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-012024-01-30C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-022024-01-30C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-032024-01-30C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-102024-01-30C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-202024-01-30C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190
0573-0190-302024-01-30C16284748780-11030e365-63fb-111a-e063-dadaa90a10e2Advil MultiSymptom Cold and Flu NDC 0573-0190

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

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
0573-0190-010057301900150 POUCH in 1 TRAY (0573-0190-01) / 1 TABLET, COATED in 1 POUCH50 pouch2018-06-250000-00-00NoNoCurrent
0573-0190-02005730190022 POUCH in 1 CARTON (0573-0190-02) / 1 TABLET, COATED in 1 POUCH2 pouch2019-11-010000-00-00NoNoCurrent
0573-0190-03005730190033000 POUCH in 1 CASE (0573-0190-03) / 1 TABLET, COATED in 1 POUCH3000 pouch2018-06-250000-00-00NoNoCurrent
0573-0190-10005730190101 BLISTER PACK in 1 CARTON (0573-0190-10) / 10 TABLET, COATED in 1 BLISTER PACK1 blister pack2018-06-250000-00-00NoNoCurrent
0573-0190-20005730190202 BLISTER PACK in 1 CARTON (0573-0190-20) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-06-250000-00-00NoNoCurrent
0573-0190-30005730190303 BLISTER PACK in 1 CARTON (0573-0190-30) / 10 TABLET, COATED in 1 BLISTER PACK3 blister pack2018-06-250000-00-00NoNoCurrent