FDA.reportPublic FDA data

ADVIL DUAL ACTION WITH ACETAMINOPHEN

Product NDC
67751-211
11-digit product format
677510211
Labeler code
67751
Product ID
67751-211_16264d4c-f111-10c1-e063-6294a90a9beb
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen, Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA211733
Marketing category
NDA
Marketing start
2021-05-21
Substance
ACETAMINOPHEN; IBUPROFEN
Active strength
250; 125 mg/1; 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 DUAL ACTION WITH ACETAMINOPHEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
IBUPROFEN125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, WK2XYI10QM
Rxcui2387532

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
67751-211-012024-04-15C16284748780-11030e365-60c0-111a-e063-dadaa90a10e2Advil Dual Action with Acetaminophen
67751-211-022024-04-15C16284748780-11030e365-60c0-111a-e063-dadaa90a10e2Advil Dual Action with Acetaminophen
67751-211-012024-01-30C16284748780-11030e365-60c0-111a-e063-dadaa90a10e2Advil Dual Action with Acetaminophen
67751-211-022024-01-30C16284748780-11030e365-60c0-111a-e063-dadaa90a10e2Advil Dual Action with Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-211-01ADVIL DUAL ACTION WITH ACETAMINOPHEN1 in 1 CARTONTABLET, FILM COATED13
67751-211-01ADVIL DUAL ACTION WITH ACETAMINOPHEN2 in 1 POUCHTABLET, FILM COATED23
67751-211-02ADVIL DUAL ACTION WITH ACETAMINOPHEN2 in 1 POUCHTABLET, FILM COATED23
67751-211-02ADVIL DUAL ACTION WITH ACETAMINOPHEN2 in 1 CARTONTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-211ADVIL DUAL ACTION WITH ACETAMINOPHEN (IBUPROFEN, ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]3Current NDC, Legacy NDC, 4 package rows20240417_bd0d7812-4e42-b533-e053-2995a90ae1f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSNbd0d7812-4e42-b533-e053-2995a90ae1f93
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCDbd0d7812-4e42-b533-e053-2995a90ae1f93
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSYbd0d7812-4e42-b533-e053-2995a90ae1f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-211-01677510211011 POUCH in 1 CARTON (67751-211-01) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2021-05-210000-00-00NoNoCurrent
67751-211-02677510211022 POUCH in 1 CARTON (67751-211-02) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2021-05-210000-00-00NoNoCurrent