FDA.reportPublic FDA data

Advil

Product NDC
66715-9700
11-digit product format
667159700
Labeler code
66715
Product ID
66715-9700_2cb6ac3b-ffe3-21bc-e063-6394a90a4569
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA018989
Marketing category
NDA
Marketing start
2010-02-22
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
66715-9700-12024-01-30C16284748780-11030e365-08c4-111a-e063-dadaa90a10e2Advil ® Tablets
66715-9700-22024-01-30C16284748780-11030e365-08c4-111a-e063-dadaa90a10e2Advil ® Tablets
66715-9700-32024-01-30C16284748780-11030e365-08c4-111a-e063-dadaa90a10e2Advil ® Tablets
66715-9700-82024-01-30C16284748780-11030e365-08c4-111a-e063-dadaa90a10e2Advil ® Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9700-1Advil1 in 1 CARTONTABLET, COATED112
66715-9700-1Advil2 in 1 POUCHTABLET, COATED212
66715-9700-2Advil2 in 1 POUCHTABLET, COATED212
66715-9700-2Advil2 in 1 CARTONTABLET, COATED212
66715-9700-3Advil2 in 1 POUCHTABLET, COATED212
66715-9700-3Advil3 in 1 CARTONTABLET, COATED312
66715-9700-7Advil30 in 1 BOX, UNIT-DOSETABLET, COATED3012
66715-9700-7Advil2 in 1 POUCHTABLET, COATED212
66715-9700-8Advil6 in 1 CARTONTABLET, COATED612
66715-9700-8Advil2 in 1 POUCHTABLET, COATED212

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
IbuprofenACTIVE MOIETYWK2XYI10QMADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
diacetylated monoglyceridesINACTIVE INGREDIENT5Z17386USFADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
povidonesINACTIVE INGREDIENTFZ989GH94EADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
shellacINACTIVE INGREDIENT46N107B71OADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9700ADVIL (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]12Current NDC, Legacy NDC, 10 package rows20250130_772360bd-8631-4d24-b4db-5a7e6e1d9a13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSN772360bd-8631-4d24-b4db-5a7e6e1d9a1312
310965ibuprofen 200 MG Oral TabletPSN772360bd-8631-4d24-b4db-5a7e6e1d9a1312
153008ibuprofen 200 MG Oral Tablet [Advil]SBD772360bd-8631-4d24-b4db-5a7e6e1d9a1312
310965ibuprofen 200 MG Oral TabletSCD772360bd-8631-4d24-b4db-5a7e6e1d9a1312
153008Advil 200 MG Oral TabletSY772360bd-8631-4d24-b4db-5a7e6e1d9a1312
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY772360bd-8631-4d24-b4db-5a7e6e1d9a1312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9700-1667159700011 POUCH in 1 CARTON (66715-9700-1) > 2 TABLET, COATED in 1 POUCH1 pouch2018-12-150000-00-00NoNoCurrent
66715-9700-2667159700022 POUCH in 1 CARTON (66715-9700-2) / 2 TABLET, COATED in 1 POUCH2 pouch2018-12-150000-00-00NoNoCurrent
66715-9700-3667159700033 POUCH in 1 CARTON (66715-9700-3) / 2 TABLET, COATED in 1 POUCH3 pouch2018-12-150000-00-00NoNoCurrent
66715-9700-76671597000730 POUCH in 1 BOX, UNIT-DOSE (66715-9700-7) / 2 TABLET, COATED in 1 POUCH30 pouch2022-04-19NoNoHistorical
66715-9700-8667159700086 in 1 CARTONHistorical