Equaline ibuprofen

Product NDC
41163-166
11-digit product format
411630166
Labeler code
41163
Product ID
41163-166_a657ed38-635e-4ddc-8a24-d01dba21de87
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA074937
Marketing category
ANDA
Marketing start
2004-10-07
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
Equaline ibuprofen
Brand name suffix
childrens
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
41163-166-26Equaline ibuprofenchildrens118 mL in 1 BOTTLESUSPENSION1187
41163-166-26Equaline ibuprofenchildrens1 in 1 CARTONSUSPENSION17
41163-166-28Equaline ibuprofenchildrens1 in 1 CARTONSUSPENSION17
41163-166-28Equaline ibuprofenchildrens148 mL in 1 BOTTLESUSPENSION1487
41163-166-34Equaline ibuprofenchildrens240 mL in 1 BOTTLESUSPENSION2407
41163-166-34Equaline ibuprofenchildrens1 in 1 CARTONSUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-166-26ML - Milliliter41163-16664b9c887-2faa-42b0-b367-b0ac1177e16512012-07-24
41163-166-34ML - Milliliter41163-1660372c085-54a6-46aa-beda-3339f2a2041712016-10-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-166EQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 6 package rows20250515_811d4360-7468-4ef8-a60e-6e9a6e169de0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN811d4360-7468-4ef8-a60e-6e9a6e169de07
197803ibuprofen 20 MG/ML Oral SuspensionSCD811d4360-7468-4ef8-a60e-6e9a6e169de07
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY811d4360-7468-4ef8-a60e-6e9a6e169de07
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY811d4360-7468-4ef8-a60e-6e9a6e169de07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-166-26411630166261 BOTTLE in 1 CARTON (41163-166-26) / 118 mL in 1 BOTTLE1 bottle2004-10-070000-00-00NoNoCurrent
41163-166-28411630166281 BOTTLE in 1 CARTON (41163-166-28) > 148 mL in 1 BOTTLE1 bottle2012-09-240000-00-00NoNoCurrent
41163-166-34411630166341 BOTTLE in 1 CARTON (41163-166-34) > 240 mL in 1 BOTTLE1 bottle2012-01-300000-00-00NoNoCurrent