FDA.reportPublic FDA data

Advil

Product NDC
67751-146
11-digit product format
677510146
Labeler code
67751
Product ID
67751-146_4efb2a06-f0fc-b6d2-e063-6294a90a92d4
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA018989
Marketing category
NDA
Marketing start
2016-09-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Advil
Listing expiration
2027-12-31

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
67751-146-012023-03-15C16284748780-1f386c64a-0d89-0266-e053-dadaa90a7c1aAdvil
67751-146-022023-03-15C16284748780-1f386c64a-0d89-0266-e053-dadaa90a7c1aAdvil
67751-146-032023-03-15C16284748780-1f386c64a-0d89-0266-e053-dadaa90a7c1aAdvil
67751-146-012023-01-30C16284748780-1f386c64a-0d89-0266-e053-dadaa90a7c1aAdvil
67751-146-022023-01-30C16284748780-1f386c64a-0d89-0266-e053-dadaa90a7c1aAdvil
67751-146-032023-01-30C16284748780-1f386c64a-0d89-0266-e053-dadaa90a7c1aAdvil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-146-01Advil1 in 1 CARTONTABLET, COATED15
67751-146-01Advil2 in 1 POUCHTABLET, COATED25
67751-146-02Advil2 in 1 POUCHTABLET, COATED25
67751-146-02Advil2 in 1 CARTONTABLET, COATED25
67751-146-03Advil12 in 1 TRAYTABLET, COATED125
67751-146-03Advil2 in 1 POUCHTABLET, COATED25
67751-146-06Advil3 in 1 CARTONTABLET, COATED35
67751-146-06Advil2 in 1 POUCHTABLET, COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-146ADVIL (IBUPROFEN) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]4Current NDC, Legacy NDC, 8 package rows20230317_4a64522f-b7d8-47f7-bf07-c9e8f1086425.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153008Advil 200 MG Oral TabletPSN4a64522f-b7d8-47f7-bf07-c9e8f10864255
310965ibuprofen 200 MG Oral TabletPSN4a64522f-b7d8-47f7-bf07-c9e8f10864255
153008ibuprofen 200 MG Oral Tablet [Advil]SBD4a64522f-b7d8-47f7-bf07-c9e8f10864255
310965ibuprofen 200 MG Oral TabletSCD4a64522f-b7d8-47f7-bf07-c9e8f10864255
153008Advil 200 MG Oral TabletSY4a64522f-b7d8-47f7-bf07-c9e8f10864255
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4a64522f-b7d8-47f7-bf07-c9e8f10864255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-146-01677510146011 POUCH in 1 CARTON (67751-146-01) / 2 TABLET, COATED in 1 POUCH1 pouch2016-09-200000-00-00NoNoCurrent
67751-146-02677510146022 POUCH in 1 CARTON (67751-146-02) / 2 TABLET, COATED in 1 POUCH2 pouch2016-09-200000-00-00NoNoCurrent
67751-146-036775101460312 POUCH in 1 TRAY (67751-146-03) > 2 TABLET, COATED in 1 POUCH12 pouch2016-09-200000-00-00NoNoCurrent
67751-146-06677510146063 POUCH in 1 CARTON (67751-146-06) / 2 TABLET, COATED in 1 POUCH3 pouch2025-04-21NoNoCurrent