profen ib

Product NDC
56062-057
11-digit product format
560620057
Labeler code
56062
Product ID
56062-057_44e24e10-b8fa-4992-a35f-01c664914844
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA075217
Marketing category
ANDA
Marketing start
2001-06-29
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
profen ib
Brand name suffix
infants
Listing expiration
2026-12-31

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
56062-057-05profen ibinfants1 in 1 CARTONSUSPENSION15
56062-057-05profen ibinfants15 mL in 1 BOTTLESUSPENSION155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
56062-057-05ML - Milliliter56062-05705340546-f979-45f2-91e2-efc214ed199d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8PROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
WATERINACTIVE INGREDIENT059QF0KO0RPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-057PROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC]4Current NDC, Legacy NDC, 2 package rows20181103_84aea3fc-4f3b-4a76-a3a6-94ed6549dbea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN84aea3fc-4f3b-4a76-a3a6-94ed6549dbea5
204442ibuprofen 40 MG/ML Oral SuspensionSCD84aea3fc-4f3b-4a76-a3a6-94ed6549dbea5
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY84aea3fc-4f3b-4a76-a3a6-94ed6549dbea5
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY84aea3fc-4f3b-4a76-a3a6-94ed6549dbea5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-057-05560620057051 BOTTLE in 1 CARTON (56062-057-05) / 15 mL in 1 BOTTLE1 bottle2001-06-290000-00-00NoNoCurrent