FDA.reportPublic FDA data

Advil Menstrual Pain

Product NDC
0573-0230
11-digit product format
005730230
Labeler code
0573
Product ID
0573-0230_5b08a4cf-a90b-42ed-b449-c250cdc0a5f4
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA201803
Marketing category
NDA
Marketing start
2016-06-30
Substance
IBUPROFEN SODIUM
Active strength
256 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 Menstrual Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN SODIUM256 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRM1CE97Z4N
Rxcui153008, 310965

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
0573-0230-202024-01-31C16284748780-11030e365-4a7f-111a-e063-dadaa90a10e2Drug Facts
0573-0230-402024-01-31C16284748780-11030e365-4a7f-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0230-20Advil Menstrual Pain1 in 1 CARTONTABLET, COATED16
0573-0230-20Advil Menstrual Pain20 in 1 BOTTLETABLET, COATED206
0573-0230-40Advil Menstrual Pain1 in 1 CARTONTABLET, COATED16
0573-0230-40Advil Menstrual Pain40 in 1 BOTTLETABLET, COATED406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0230ADVIL MENSTRUAL PAIN (IBUPROFEN SODIUM) TABLET, COATED [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20240201_ae1625f4-ef32-4d4f-bf54-c44085843e41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSNae1625f4-ef32-4d4f-bf54-c44085843e416
310965ibuprofen 200 MG Oral TabletPSNae1625f4-ef32-4d4f-bf54-c44085843e416
153008ibuprofen 200 MG Oral Tablet [Advil]SBDae1625f4-ef32-4d4f-bf54-c44085843e416
310965ibuprofen 200 MG Oral TabletSCDae1625f4-ef32-4d4f-bf54-c44085843e416
153008Advil 200 MG Oral TabletSYae1625f4-ef32-4d4f-bf54-c44085843e416
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYae1625f4-ef32-4d4f-bf54-c44085843e416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0230-20005730230201 BOTTLE in 1 CARTON (0573-0230-20) / 20 TABLET, COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
0573-0230-40005730230401 BOTTLE in 1 CARTON (0573-0230-40) / 40 TABLET, COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent