FDA.reportPublic FDA data

good sense ibuprofen

Product NDC
0113-0166
11-digit product format
001130166
Labeler code
0113
Product ID
0113-0166_58309f59-0bb3-45f9-87fe-2f64f1cf4b04
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
2002-05-04
Substance
IBUPROFEN
Active strength
100 mg/5mL
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
good sense ibuprofen
Brand name suffix
childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
0113-0166-26good sense ibuprofenchildrens120 mL in 1 BOTTLESUSPENSION1207
0113-0166-26good sense ibuprofenchildrens1 in 1 CARTONSUSPENSION17
0113-0166-28good sense ibuprofenchildrens1 in 1 CARTONSUSPENSION17
0113-0166-28good sense ibuprofenchildrens150 mL in 1 BOTTLESUSPENSION1507
0113-0166-34good sense ibuprofenchildrens1 in 1 CARTONSUSPENSION17
0113-0166-34good sense ibuprofenchildrens240 mL in 1 BOTTLESUSPENSION2407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0166-26ML - Milliliter0113-016658d28c1c-52e8-40f3-9d73-0e6d15293a4012012-07-24
0113-0166-34ML - Milliliter0113-0166b2db1ec4-53ec-4434-9d2e-07fd276b85db12021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0166GOOD SENSE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 6 package rows20250514_b8e3ad4f-3212-4674-bcdf-a60a6b23d7bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNb8e3ad4f-3212-4674-bcdf-a60a6b23d7bb7
197803ibuprofen 20 MG/ML Oral SuspensionSCDb8e3ad4f-3212-4674-bcdf-a60a6b23d7bb7
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYb8e3ad4f-3212-4674-bcdf-a60a6b23d7bb7
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYb8e3ad4f-3212-4674-bcdf-a60a6b23d7bb7
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN7ac61180-d668-4eec-b04f-d14f7b552a4d1
197803ibuprofen 20 MG/ML Oral SuspensionSCD7ac61180-d668-4eec-b04f-d14f7b552a4d1
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY7ac61180-d668-4eec-b04f-d14f7b552a4d1
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY7ac61180-d668-4eec-b04f-d14f7b552a4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0166-26001130166261 BOTTLE in 1 CARTON (0113-0166-26) / 120 mL in 1 BOTTLE1 bottle2002-05-040000-00-00NoNoCurrent
0113-0166-28001130166281 BOTTLE in 1 CARTON (0113-0166-28) > 150 mL in 1 BOTTLE1 bottle2013-05-280000-00-00NoNoCurrent
0113-0166-34001130166341 BOTTLE in 1 CARTON (0113-0166-34) / 240 mL in 1 BOTTLE1 bottle2020-02-110000-00-00NoNoCurrent