Good Sense ibuprofen

Product NDC
0113-0057
11-digit product format
001130057
Labeler code
0113
Product ID
0113-0057_99c7780e-159c-4da7-b22c-879c08458252
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA075217
Marketing category
ANDA
Marketing start
2000-02-08
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense ibuprofen
Brand name suffix
infants
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442

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
0113-0057-05Good Sense ibuprofeninfants1 in 1 CARTONSUSPENSION14
0113-0057-05Good Sense ibuprofeninfants15 mL in 1 BOTTLESUSPENSION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0057-05ML - Milliliter0113-005741891602-d8b0-4122-a929-a6f641baa79612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
SORBITOLINACTIVE INGREDIENT506T60A25RGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
SUCROSEINACTIVE INGREDIENTC151H8M554GOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0057GOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 2 package rows20171226_c79e65e7-149b-450f-b083-99e16ff71729.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNc79e65e7-149b-450f-b083-99e16ff717294
204442ibuprofen 40 MG/ML Oral SuspensionSCDc79e65e7-149b-450f-b083-99e16ff717294
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYc79e65e7-149b-450f-b083-99e16ff717294
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYc79e65e7-149b-450f-b083-99e16ff717294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0057-05001130057051 BOTTLE in 1 CARTON (0113-0057-05) / 15 mL in 1 BOTTLE1 bottle2000-02-080000-00-00NoNoCurrent