FDA.reportPublic FDA data

Childrens Ibuprofen fruit

Product NDC
53041-632
11-digit product format
530410632
Labeler code
53041
Product ID
53041-632_e690a788-b856-44b3-afff-bb950d1eb117
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA210149
Marketing category
ANDA
Marketing start
2021-10-13
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
Childrens Ibuprofen fruit
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
53041-632-03Childrens Ibuprofen fruit1 in 1 CARTONSUSPENSION/ DROPS12
53041-632-03Childrens Ibuprofen fruit120 mL in 1 BOTTLESUSPENSION/ DROPS1202
53041-632-04Childrens Ibuprofen fruit240 mL in 1 BOTTLESUSPENSION/ DROPS2402
53041-632-04Childrens Ibuprofen fruit1 in 1 CARTONSUSPENSION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-632CHILDRENS IBUPROFEN BUBBLEGUM (IBUPROFEN) SUSPENSION/ DROPS CHILDRENS IBUPROFEN GRAPE (IBUPROFEN) SUSPENSION/ DROPS CHILDRENS IBUPROFEN BLUE RASPBERRY (IBUPROFEN) SUSPENSION/ DROPS CHILDRENS IBUPROFEN FRUIT (IBUPROFEN) SUSPENSION/ DROPS [GUARDIAN DRUG COMPANY]2Current NDC, Legacy NDC, 4 package rows20211015_9cb92af9-a829-4f54-b8f5-4e5cb4f165b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9cb92af9-a829-4f54-b8f5-4e5cb4f165b72
197803ibuprofen 20 MG/ML Oral SuspensionSCD9cb92af9-a829-4f54-b8f5-4e5cb4f165b72
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9cb92af9-a829-4f54-b8f5-4e5cb4f165b72
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9cb92af9-a829-4f54-b8f5-4e5cb4f165b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-632-03530410632031 BOTTLE in 1 CARTON (53041-632-03) / 120 mL in 1 BOTTLE1 bottle2021-10-130000-00-00NoNoCurrent
53041-632-04530410632041 BOTTLE in 1 CARTON (53041-632-04) / 240 mL in 1 BOTTLE1 bottle2021-10-130000-00-00NoNoCurrent