FDA.reportPublic FDA data

Advil

Product NDC
0573-1769
11-digit product format
005731769
Labeler code
0573
Product ID
0573-1769_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
2017-03-08
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
0573-1769-092024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-1769-132024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-1769-142024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-1769-202024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-1769-802024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts
0573-1769-892024-01-31C16284748780-11030e365-6404-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-1769-02Advil2 in 1 PACKETCAPSULE, LIQUID FILLED236
0573-1769-02Advil50 in 1 CARTONCAPSULE, LIQUID FILLED5036
0573-1769-09Advil1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED136
0573-1769-09Advil8 in 1 VIALCAPSULE, LIQUID FILLED836
0573-1769-13Advil200 in 1 BOTTLECAPSULE, LIQUID FILLED20036
0573-1769-14Advil240 in 1 BOTTLECAPSULE, LIQUID FILLED24036
0573-1769-16Advil2 in 1 CARTONCAPSULE, LIQUID FILLED236
0573-1769-16Advil80 in 1 BOTTLECAPSULE, LIQUID FILLED8036
0573-1769-20Advil20 in 1 BOTTLECAPSULE, LIQUID FILLED2036
0573-1769-20Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-1769-31Advil30 in 1 BOTTLECAPSULE, LIQUID FILLED3036
0573-1769-31Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-1769-80Advil80 in 1 BOTTLECAPSULE, LIQUID FILLED8036
0573-1769-80Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-1769-87Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-1769-87Advil100 in 1 BOTTLECAPSULE, LIQUID FILLED10036
0573-1769-89Advil160 in 1 BOTTLECAPSULE, LIQUID FILLED16036
0573-1769-89Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-1769-92Advil1 in 1 CARTONCAPSULE, LIQUID FILLED136
0573-1769-92Advil180 in 1 BOTTLECAPSULE, LIQUID FILLED18036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-1769-09EA - Each0573-1769a38c6e98-9566-46ac-9a8c-3c07058d6f1312022-06-06
0573-1769-13EA - Each0573-17691d1a9485-1e97-4716-a3cf-abcdaa7d38d712022-06-06
0573-1769-20EA - Each0573-17692d12d3d1-3483-4107-8daf-2ca934f6339612020-07-13
0573-1769-80EA - Each0573-1769c3311e0f-62eb-4a8d-8a11-202c233e69c512020-07-13
0573-1769-89EA - Each0573-17696455ca56-0fe7-4ef0-ac45-2a4ab662fd9112022-06-06

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
0573-1769ADVIL (IBUPROFEN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]34Current NDC, Legacy NDC, 20 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-1769-020057317690250 PACKET in 1 CARTON (0573-1769-02) / 2 CAPSULE, LIQUID FILLED in 1 PACKET50 packet2018-06-01NoNoHistorical
0573-1769-09005731769091 VIAL in 1 BLISTER PACK (0573-1769-09) / 8 CAPSULE, LIQUID FILLED in 1 VIAL1 vial2018-06-010000-00-00NoNoCurrent
0573-1769-1300573176913200 CAPSULE, LIQUID FILLED in 1 BOTTLE (0573-1769-13) 2018-06-010000-00-00NoNoCurrent
0573-1769-1400573176914240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0573-1769-14) 2018-12-010000-00-00NoNoCurrent
0573-1769-16005731769162 BOTTLE in 1 CARTON (0573-1769-16) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE2 bottle2025-03-28NoNoHistorical
0573-1769-20005731769201 BOTTLE in 1 CARTON (0573-1769-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-03-080000-00-00NoNoCurrent
0573-1769-31005731769311 BOTTLE in 1 CARTON (0573-1769-31) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-04-01NoNoHistorical
0573-1769-80005731769801 BOTTLE in 1 CARTON (0573-1769-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-03-080000-00-00NoNoCurrent
0573-1769-87005731769871 BOTTLE in 1 CARTON (0573-1769-87) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-02-01NoNoHistorical
0573-1769-89005731769891 BOTTLE in 1 CARTON (0573-1769-89) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-03-080000-00-00NoNoCurrent
0573-1769-92005731769921 BOTTLE in 1 CARTON (0573-1769-92) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-04-01NoNoHistorical