FDA.reportPublic FDA data

Fast Pain Relief

Product NDC
69517-111
11-digit product format
695170111
Labeler code
69517
Product ID
69517-111_8e733e89-3460-49b9-a157-4f2f91bb14cc
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HealthLife of USA LLC
Application
ANDA079174
Marketing category
ANDA
Marketing start
2011-01-01
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
Fast Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
69517-111-02Fast Pain Relief2 in 1 POUCHTABLET, COATED24
69517-111-05Fast Pain Relief500 in 1 BOTTLETABLET, COATED5004
69517-111-10Fast Pain Relief1000 in 1 BOTTLETABLET, COATED10004
69517-111-25Fast Pain Relief25 in 1 CARTONTABLET, COATED254
69517-111-25Fast Pain Relief2 in 1 POUCHTABLET, COATED24
69517-111-30Fast Pain Relief1 in 1 CARTONTABLET, COATED14
69517-111-30Fast Pain Relief30 in 1 BOTTLETABLET, COATED304
69517-111-50Fast Pain Relief2 in 1 POUCHTABLET, COATED24
69517-111-50Fast Pain Relief50 in 1 CARTONTABLET, COATED504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-111FAST PAIN RELIEF (IBUPROFEN) TABLET, COATED [HEALTHLIFE OF USA LLC]4Current NDC, Legacy NDC, 9 package rows20170606_a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa3fcd34a-6aa9-477c-bbfb-2f6b36e06b654
310965ibuprofen 200 MG Oral TabletSCDa3fcd34a-6aa9-477c-bbfb-2f6b36e06b654
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa3fcd34a-6aa9-477c-bbfb-2f6b36e06b654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69517-111-02695170111022 POUCH in 1 POUCH (69517-111-02) / 2 TABLET, COATED in 1 POUCH2 pouch2016-04-060000-00-00NoNoCurrent
69517-111-0569517011105500 in 1 BOTTLEHistorical
69517-111-10695170111101000 BOTTLE in 1 BOTTLE (69517-111-10) / 500 BOTTLE in 1 BOTTLE (69517-111-05) / 30 CARTON in 1 BOTTLE (69517-111-30) / 1 TABLET, COATED in 1 CARTON1000 bottle2016-04-060000-00-00NoNoCurrent
69517-111-256951701112525 POUCH in 1 CARTON (69517-111-25) / 2 TABLET, COATED in 1 POUCH25 pouch2016-04-060000-00-00NoNoCurrent
69517-111-30695170111301 in 1 CARTONHistorical
69517-111-506951701115050 POUCH in 1 CARTON (69517-111-50) / 2 TABLET, COATED in 1 POUCH50 pouch2016-04-060000-00-00NoNoCurrent