FDA.reportPublic FDA data

Ibuprofen

Product NDC
55910-197
11-digit product format
559100197
Labeler code
55910
Product ID
55910-197_9bcf0bae-dc0d-454f-8d77-6a80a3c55bb0
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-04-30
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
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
55910-197-12Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED13
55910-197-12Ibuprofen120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1203
55910-197-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED203
55910-197-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED13
55910-197-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED403
55910-197-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED13
55910-197-80Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED13
55910-197-80Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-197IBUPROFEN CAPSULE, LIQUID FILLED [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Current NDC, Legacy NDC, 8 package rows20221108_7f510feb-023c-4974-af6d-3e7a30cef362.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN7f510feb-023c-4974-af6d-3e7a30cef3623
310964ibuprofen 200 MG Oral CapsuleSCD7f510feb-023c-4974-af6d-3e7a30cef3623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-197-12559100197121 BOTTLE, PLASTIC in 1 BOX (55910-197-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent
55910-197-20559100197201 BOTTLE, PLASTIC in 1 BOX (55910-197-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent
55910-197-40559100197401 BOTTLE, PLASTIC in 1 BOX (55910-197-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent
55910-197-80559100197801 BOTTLE, PLASTIC in 1 BOX (55910-197-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent