FDA.reportPublic FDA data

Advil

Product NDC
66715-5803
11-digit product format
667155803
Labeler code
66715
Product ID
66715-5803_1d786176-599d-19ad-e063-6294a90a9237
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen Tablets, coated
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA018989
Marketing category
NDA
Marketing start
2006-11-16
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
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
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
66715-5803-02024-01-30C16284748780-11030e365-3553-111a-e063-dadaa90a10e2Advil ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-5803-0Advil2 in 1 POUCHTABLET, COATED22
66715-5803-0Advil30 in 1 BOX, UNIT-DOSETABLET, COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5803ADVIL (IBUPROFEN TABLETS, COATED) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, Legacy NDC, 2 package rows20240719_dd302e18-39e9-7e1a-e053-2a95a90a5f7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSNdd302e18-39e9-7e1a-e053-2a95a90a5f7c2
310965ibuprofen 200 MG Oral TabletPSNdd302e18-39e9-7e1a-e053-2a95a90a5f7c2
153008ibuprofen 200 MG Oral Tablet [Advil]SBDdd302e18-39e9-7e1a-e053-2a95a90a5f7c2
310965ibuprofen 200 MG Oral TabletSCDdd302e18-39e9-7e1a-e053-2a95a90a5f7c2
153008Advil 200 MG Oral TabletSYdd302e18-39e9-7e1a-e053-2a95a90a5f7c2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYdd302e18-39e9-7e1a-e053-2a95a90a5f7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-5803-06671558030030 POUCH in 1 BOX, UNIT-DOSE (66715-5803-0) / 2 TABLET, COATED in 1 POUCH30 pouch2006-11-160000-00-00NoNoCurrent