FDA.reportPublic FDA data

ADVIL MIGRAINE

Product NDC
0573-0168
11-digit product format
005730168
Labeler code
0573
Product ID
0573-0168_4042c2e6-d403-0b28-e063-6394a90a1a94
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020402
Marketing category
NDA
Marketing start
2000-03-16
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [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 MIGRAINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964, 731533

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
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0168-202024-01-31C16284748780-11030e365-4d6a-111a-e063-dadaa90a10e2Drug Facts
0573-0168-302024-01-31C16284748780-11030e365-4d6a-111a-e063-dadaa90a10e2Drug Facts
0573-0168-402024-01-31C16284748780-11030e365-4d6a-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0168-20ADVIL MIGRAINE1 in 1 CARTONCAPSULE, LIQUID FILLED114
0573-0168-20ADVIL MIGRAINE20 in 1 BOTTLECAPSULE, LIQUID FILLED2014
0573-0168-30ADVIL MIGRAINE40 in 1 BOTTLECAPSULE, LIQUID FILLED4014
0573-0168-30ADVIL MIGRAINE1 in 1 CARTONCAPSULE, LIQUID FILLED114
0573-0168-40ADVIL MIGRAINE1 in 1 CARTONCAPSULE, LIQUID FILLED114
0573-0168-40ADVIL MIGRAINE80 in 1 BOTTLECAPSULE, LIQUID FILLED8014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0168-20EA - Each0573-0168feec2afc-1568-4618-bf50-6e30d394343812012-07-24
0573-0168-30EA - Each0573-0168f0189b18-316b-4562-a067-96974923eda812012-07-24
0573-0168-40EA - Each0573-01683d739668-e89f-4a57-9aa7-68e2a5a0dafa12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
GELATININACTIVE INGREDIENT2G86QN327LADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
SORBITANINACTIVE INGREDIENT6O92ICV9RUADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
SORBITOLINACTIVE INGREDIENT506T60A25RADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4
WATERINACTIVE INGREDIENT059QF0KO0RADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0168ADVIL MIGRAINE (IBUPROFEN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 6 package rows20240625_e4a6219d-4ad4-0119-4cf8-7fc39b4b5979.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731533Advil 200 MG Oral CapsulePSNe4a6219d-4ad4-0119-4cf8-7fc39b4b597914
310964ibuprofen 200 MG Oral CapsulePSNe4a6219d-4ad4-0119-4cf8-7fc39b4b597914
731533ibuprofen 200 MG Oral Capsule [Advil]SBDe4a6219d-4ad4-0119-4cf8-7fc39b4b597914
310964ibuprofen 200 MG Oral CapsuleSCDe4a6219d-4ad4-0119-4cf8-7fc39b4b597914
731533Advil 200 MG Oral CapsuleSYe4a6219d-4ad4-0119-4cf8-7fc39b4b597914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0168-20005730168201 BOTTLE in 1 CARTON (0573-0168-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2000-03-160000-00-00NoNoCurrent
0573-0168-30005730168301 BOTTLE in 1 CARTON (0573-0168-30) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2000-03-160000-00-00NoNoCurrent
0573-0168-40005730168401 BOTTLE in 1 CARTON (0573-0168-40) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2000-03-160000-00-00NoNoCurrent