FDA.reportPublic FDA data

Ibuprofen infants Drops

Product NDC
53943-637
11-digit product format
539430637
Labeler code
53943
Product ID
53943-637_e3a822e2-5d80-4966-9245-6ca09f8b6689
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Discount Drug Mart, Inc
Application
ANDA210755
Marketing category
ANDA
Marketing start
2025-02-13
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
Ibuprofen infants Drops
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-637-09Ibuprofen infants Drops30 mL in 1 BOTTLESUSPENSION/ DROPS302
53943-637-09Ibuprofen infants Drops1 in 1 CARTONSUSPENSION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-637IBUPROFEN INFANTS DROPS (IBUPROFEN) SUSPENSION/ DROPS [DISCOUNT DRUG MART, INC]2Current NDC, 2 package rows20250226_2d582242-8b63-b51d-e063-6394a90a979a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN2d582242-8b63-b51d-e063-6394a90a979a2
204442ibuprofen 40 MG/ML Oral SuspensionSCD2d582242-8b63-b51d-e063-6394a90a979a2
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY2d582242-8b63-b51d-e063-6394a90a979a2
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY2d582242-8b63-b51d-e063-6394a90a979a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-637-09539430637091 BOTTLE in 1 CARTON (53943-637-09) / 30 mL in 1 BOTTLE1 bottle2025-02-13NoNoHistorical