FDA.reportPublic FDA data

Advil

Product NDC
50269-157
11-digit product format
502690157
Labeler code
50269
Product ID
50269-157_388efabc-1749-3a11-e063-6394a90a8a32
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, COATED
Route
TOPICAL
Labeler
JC World Bell Wholesale Co., Inc.
Application
NDA018989
Marketing category
NDA
Marketing start
1984-05-18
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
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
50269-157-012024-01-30C16284748780-11030e365-5cd7-111a-e063-dadaa90a10e2Advil
50269-157-022024-01-30C16284748780-11030e365-5cd7-111a-e063-dadaa90a10e2Advil
50269-157-032024-01-30C16284748780-11030e365-5cd7-111a-e063-dadaa90a10e2Advil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50269-157-01Advil1 in 1 BLISTER PACKTABLET, COATED16
50269-157-01Advil6 in 1 BOXTABLET, COATED66
50269-157-02Advil6 in 1 BOXTABLET, COATED66
50269-157-02Advil2 in 1 BLISTER PACKTABLET, COATED26
50269-157-03Advil2 in 1 POUCHTABLET, COATED26
50269-157-03Advil25 in 1 BOXTABLET, COATED256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50269-157ADVIL (IBUPROFEN) TABLET, COATED [JC WORLD BELL WHOLESALE CO., INC.]5Current NDC, 6 package rows20241225_0b83c9ed-3630-4c5c-9020-cf38183a6500.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSN0b83c9ed-3630-4c5c-9020-cf38183a65006
310965ibuprofen 200 MG Oral TabletPSN0b83c9ed-3630-4c5c-9020-cf38183a65006
153008ibuprofen 200 MG Oral Tablet [Advil]SBD0b83c9ed-3630-4c5c-9020-cf38183a65006
310965ibuprofen 200 MG Oral TabletSCD0b83c9ed-3630-4c5c-9020-cf38183a65006
153008Advil 200 MG Oral TabletSY0b83c9ed-3630-4c5c-9020-cf38183a65006
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY0b83c9ed-3630-4c5c-9020-cf38183a65006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50269-157-01502690157016 BLISTER PACK in 1 BOX (50269-157-01) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, COATED in 1 POUCH6 blister pack1984-05-18NoNoCurrent
50269-157-02502690157026 BLISTER PACK in 1 BOX (50269-157-02) / 2 POUCH in 1 BLISTER PACK / 2 TABLET, COATED in 1 POUCH6 blister pack1984-05-18NoNoCurrent
50269-157-035026901570325 POUCH in 1 BOX (50269-157-03) / 2 TABLET, COATED in 1 POUCH25 pouch1984-05-18NoNoCurrent