Dual Action Pain Relief

Product NDC
69168-462
11-digit product format
691680462
Labeler code
69168
Product ID
69168-462_cd52df09-a439-4a7e-b593-d2255f4a2275
Type
HUMAN OTC DRUG
Nonproprietary name
Dual Action Pain Relief
Dosage form
CAPSULE
Route
ORAL
Labeler
Allegiant Health
Application
ANDA216592
Marketing category
ANDA
Marketing start
2024-03-29
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
Dual Action Pain Relief
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-462-02Dual Action Pain Relief150 in 1 BOTTLECAPSULE1504
69168-462-17Dual Action Pain Relief300 in 1 BOTTLECAPSULE3004
69168-462-35Dual Action Pain Relief80 in 1 BOTTLECAPSULE804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-462DUAL ACTION PAIN RELIEF CAPSULE [ALLEGIANT HEALTH]4Current NDC, 3 package rows20250309_fb4fc347-0f90-429f-9ca8-903e736f5496.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-462-0269168046202150 CAPSULE in 1 BOTTLE (69168-462-02) 150 capsule2024-03-29NoNoCurrent
69168-462-1769168046217300 CAPSULE in 1 BOTTLE (69168-462-17) 300 capsule2025-03-07NoNoCurrent
69168-462-356916804623580 CAPSULE in 1 BOTTLE (69168-462-35) 80 capsule2024-03-29NoNoCurrent