FDA.reportPublic FDA data

Childrens Ibuprofen

Product NDC
53041-634
11-digit product format
530410634
Labeler code
53041
Product ID
53041-634_510c1692-f23a-497b-8738-4b29e7c549e8
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA210149
Marketing category
ANDA
Marketing start
2018-08-21
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
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
53041-634-03Childrens Ibuprofen120 mL in 1 BOTTLESUSPENSION/ DROPS1202
53041-634-03Childrens Ibuprofen1 in 1 CARTONSUSPENSION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-634CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [GUARDIAN DRUG COMPANY]2Current NDC, Legacy NDC, 2 package rows20181115_694866ce-c419-4b4c-bfb2-4175703d89f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN694866ce-c419-4b4c-bfb2-4175703d89f12
197803ibuprofen 20 MG/ML Oral SuspensionSCD694866ce-c419-4b4c-bfb2-4175703d89f12
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY694866ce-c419-4b4c-bfb2-4175703d89f12
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY694866ce-c419-4b4c-bfb2-4175703d89f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-634-03530410634031 BOTTLE in 1 CARTON (53041-634-03) / 120 mL in 1 BOTTLE1 bottle2018-08-210000-00-00NoNoCurrent