FDA.reportPublic FDA data

Advil

Product NDC
0573-0169
11-digit product format
005730169
Labeler code
0573
Product ID
0573-0169_d88c288b-c728-49c9-9793-a837c989fc88
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
1995-04-10
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
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0169-022024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-082024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-112024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-132024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-172024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-192024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-202024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-222024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-302024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-312024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-402024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-432024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-492024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-512024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-522024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-762024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-862024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-0169-892024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0169-02Advil50 in 1 BOXCAPSULE, LIQUID FILLED5036
0573-0169-02Advil2 in 1 POUCHCAPSULE, LIQUID FILLED236
0573-0169-08Advil120 in 1 BOTTLECAPSULE, LIQUID FILLED12036
0573-0169-08Advil2 in 1 CARTONCAPSULE, LIQUID FILLED236
0573-0169-11Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-11Advil120 in 1 BOTTLECAPSULE, LIQUID FILLED12036
0573-0169-13Advil240 in 1 BOTTLECAPSULE, LIQUID FILLED24036
0573-0169-16Advil2 in 1 CARTONCAPSULE, LIQUID FILLED236
0573-0169-16Advil80 in 1 BOTTLECAPSULE, LIQUID FILLED8036
0573-0169-17Advil2 in 1 POUCHCAPSULE, LIQUID FILLED236
0573-0169-17Advil3000 in 1 CASECAPSULE, LIQUID FILLED300036
0573-0169-19Advil4 in 1 BLISTER PACKCAPSULE, LIQUID FILLED436
0573-0169-19Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-20Advil20 in 1 BOTTLECAPSULE, LIQUID FILLED2036
0573-0169-20Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-22Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-22Advil30 in 1 BOTTLECAPSULE, LIQUID FILLED3036
0573-0169-30Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-30Advil40 in 1 BOTTLECAPSULE, LIQUID FILLED4036
0573-0169-31Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-31Advil60 in 1 BOTTLECAPSULE, LIQUID FILLED6036
0573-0169-40Advil80 in 1 BOTTLECAPSULE, LIQUID FILLED8036
0573-0169-40Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-43Advil120 in 1 BOTTLECAPSULE, LIQUID FILLED12036
0573-0169-43Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-49Advil200 in 1 BOTTLECAPSULE, LIQUID FILLED20036
0573-0169-51Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-51Advil180 in 1 BOTTLECAPSULE, LIQUID FILLED18036
0573-0169-52Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-52Advil200 in 1 BOTTLECAPSULE, LIQUID FILLED20036
0573-0169-76Advil160 in 1 BOTTLECAPSULE, LIQUID FILLED16036
0573-0169-76Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-86Advil100 in 1 BOTTLECAPSULE, LIQUID FILLED10036
0573-0169-86Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-0169-89Advil160 in 1 BOTTLECAPSULE, LIQUID FILLED16036
0573-0169-89Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0169-02EA - Each0573-01694f76d60b-63de-4664-95aa-07dd8257908712015-10-02
0573-0169-08EA - Each0573-0169d8c1d06f-887b-4438-8e3d-a210b371033512024-04-05
0573-0169-11EA - Each0573-01699f33a1b3-3c59-4b8e-a4f3-d0aed1a2cc5f12024-04-05
0573-0169-17EA - Each0573-0169c1d0bb77-1cc4-4c29-8b4b-d9d9185c197512021-11-09
0573-0169-20EA - Each0573-0169102be152-99e7-4123-8946-99cd2af2114c12012-07-24
0573-0169-30EA - Each0573-016954ec483a-4fdb-400f-ae37-ac0db512507a12012-07-24
0573-0169-40EA - Each0573-0169f77736ad-6118-4506-9810-6e90d6ceb68712012-07-24
0573-0169-49EA - Each0573-01692e9d742d-636b-488a-ae49-4d92d0ed9ef512013-02-13
0573-0169-89EA - Each0573-0169a7791fac-dd71-40a2-b504-435b3b72942012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
GELATININACTIVE INGREDIENT2G86QN327LADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
SORBITANINACTIVE INGREDIENT6O92ICV9RUADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
SORBITOLINACTIVE INGREDIENT506T60A25RADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
WATERINACTIVE INGREDIENT059QF0KO0RADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0169ADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]34Current NDC, Legacy NDC, 36 package rows20250119_1f01c10a-9434-91a4-2ee4-352315a6b610.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731533Advil 200 MG Oral CapsulePSN1f01c10a-9434-91a4-2ee4-352315a6b61036
310964ibuprofen 200 MG Oral CapsulePSN1f01c10a-9434-91a4-2ee4-352315a6b61036
731533ibuprofen 200 MG Oral Capsule [Advil]SBD1f01c10a-9434-91a4-2ee4-352315a6b61036
310964ibuprofen 200 MG Oral CapsuleSCD1f01c10a-9434-91a4-2ee4-352315a6b61036
731533Advil 200 MG Oral CapsuleSY1f01c10a-9434-91a4-2ee4-352315a6b61036
731533Advil 200 MG Oral CapsulePSNe2c09216-fd63-4d50-9878-62b36236b2e74
310964ibuprofen 200 MG Oral CapsulePSNe2c09216-fd63-4d50-9878-62b36236b2e74
731533ibuprofen 200 MG Oral Capsule [Advil]SBDe2c09216-fd63-4d50-9878-62b36236b2e74
310964ibuprofen 200 MG Oral CapsuleSCDe2c09216-fd63-4d50-9878-62b36236b2e74
731533Advil 200 MG Oral CapsuleSYe2c09216-fd63-4d50-9878-62b36236b2e74
731533Advil 200 MG Oral CapsulePSN9fce41c2-e059-4180-9e7b-47ac506baf442
310964ibuprofen 200 MG Oral CapsulePSN9fce41c2-e059-4180-9e7b-47ac506baf442
731533ibuprofen 200 MG Oral Capsule [Advil]SBD9fce41c2-e059-4180-9e7b-47ac506baf442
310964ibuprofen 200 MG Oral CapsuleSCD9fce41c2-e059-4180-9e7b-47ac506baf442
731533Advil 200 MG Oral CapsuleSY9fce41c2-e059-4180-9e7b-47ac506baf442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0169-020057301690250 POUCH in 1 BOX (0573-0169-02) / 2 CAPSULE, LIQUID FILLED in 1 POUCH50 pouch1995-04-100000-00-00NoNoCurrent
0573-0169-08005730169082 BOTTLE in 1 CARTON (0573-0169-08) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE2 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-11005730169111 BOTTLE in 1 CARTON (0573-0169-11) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-1300573016913240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0573-0169-13) 1995-04-100000-00-00NoNoCurrent
0573-0169-16005730169162 BOTTLE in 1 CARTON (0573-0169-16) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE2 bottle2025-03-28NoNoCurrent
0573-0169-17005730169173000 POUCH in 1 CASE (0573-0169-17) / 2 CAPSULE, LIQUID FILLED in 1 POUCH3000 pouch1995-04-100000-00-00NoNoCurrent
0573-0169-19005730169191 BLISTER PACK in 1 CARTON (0573-0169-19) / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack1995-04-100000-00-00NoNoCurrent
0573-0169-20005730169201 BOTTLE in 1 CARTON (0573-0169-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-22005730169221 BOTTLE in 1 CARTON (0573-0169-22) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-30005730169301 BOTTLE in 1 CARTON (0573-0169-30) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-31005730169311 BOTTLE in 1 CARTON (0573-0169-31) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-40005730169401 BOTTLE in 1 CARTON (0573-0169-40) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-43005730169431 BOTTLE in 1 CARTON (0573-0169-43) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-4900573016949200 CAPSULE, LIQUID FILLED in 1 BOTTLE (0573-0169-49) 1995-04-100000-00-00NoNoCurrent
0573-0169-51005730169511 BOTTLE in 1 CARTON (0573-0169-51) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-52005730169521 BOTTLE in 1 CARTON (0573-0169-52) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-76005730169761 BOTTLE in 1 CARTON (0573-0169-76) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-86005730169861 BOTTLE in 1 CARTON (0573-0169-86) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent
0573-0169-89005730169891 BOTTLE in 1 CARTON (0573-0169-89) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1995-04-100000-00-00NoNoCurrent