FDA.reportPublic FDA data

care one ibuprofen

Product NDC
41520-897
11-digit product format
415200897
Labeler code
41520
Product ID
41520-897_c3c3f0bd-09c2-4bde-9eb1-0f965652e5d1
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Sales Company
Application
ANDA074937
Marketing category
ANDA
Marketing start
2004-04-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
care one ibuprofen
Listing expiration
2027-12-31

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
41520-897-26care one ibuprofen118 mL in 1 BOTTLESUSPENSION1189
41520-897-26care one ibuprofen1 in 1 CARTONSUSPENSION19
41520-897-28care one ibuprofen147 mL in 1 BOTTLESUSPENSION1479
41520-897-28care one ibuprofen1 in 1 CARTONSUSPENSION19
41520-897-34care one ibuprofen118 mL in 1 BOTTLESUSPENSION1189
41520-897-34care one ibuprofen2 in 1 CARTONSUSPENSION29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-897CARE ONE IBUPROFEN (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]8Current NDC, Legacy NDC, 6 package rows20250523_d26d2766-6d4c-462b-ae8b-ef8d87acd633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNd26d2766-6d4c-462b-ae8b-ef8d87acd6339
197803ibuprofen 20 MG/ML Oral SuspensionSCDd26d2766-6d4c-462b-ae8b-ef8d87acd6339
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYd26d2766-6d4c-462b-ae8b-ef8d87acd6339
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYd26d2766-6d4c-462b-ae8b-ef8d87acd6339

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-897-26415200897261 BOTTLE in 1 CARTON (41520-897-26) / 118 mL in 1 BOTTLE1 bottle2004-04-280000-00-00NoNoCurrent
41520-897-28415200897281 BOTTLE in 1 CARTON (41520-897-28) > 147 mL in 1 BOTTLE1 bottle2013-08-110000-00-00NoNoCurrent
41520-897-34415200897342 BOTTLE in 1 CARTON (41520-897-34) > 118 mL in 1 BOTTLE2 bottle2006-12-180000-00-00NoNoCurrent