equaline ibuprofen

Product NDC
41163-897
11-digit product format
411630897
Labeler code
41163
Product ID
41163-897_760528c7-66b3-49ab-8d1f-14e2fa321c7c
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
2004-08-30
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
41163-897-26equaline ibuprofenchildrens1 in 1 CARTONSUSPENSION17
41163-897-26equaline ibuprofenchildrens118 mL in 1 BOTTLESUSPENSION1187
41163-897-34equaline ibuprofenchildrens1 in 1 CARTONSUSPENSION17
41163-897-34equaline ibuprofenchildrens240 mL in 1 BOTTLESUSPENSION2407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-897-26ML - Milliliter41163-8971be938f0-6d13-4643-bbee-39af2c078fd312012-07-24
41163-897-34ML - Milliliter41163-89713d33c78-51a4-4a37-a8ea-7d3eb90793e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [SUPERVALU INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-897EQUALINE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [UNITED NATURAL FOODS, INC. DBA UNFI]7Current NDC, Legacy NDC, 4 package rows20250509_835c3bc8-fb55-4b7e-98ad-3d84d089c8cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN835c3bc8-fb55-4b7e-98ad-3d84d089c8cb7
197803ibuprofen 20 MG/ML Oral SuspensionSCD835c3bc8-fb55-4b7e-98ad-3d84d089c8cb7
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY835c3bc8-fb55-4b7e-98ad-3d84d089c8cb7
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY835c3bc8-fb55-4b7e-98ad-3d84d089c8cb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-897-26411630897261 BOTTLE in 1 CARTON (41163-897-26) / 118 mL in 1 BOTTLE1 bottle2004-09-240000-00-00NoNoCurrent
41163-897-34411630897341 BOTTLE in 1 CARTON (41163-897-34) > 240 mL in 1 BOTTLE1 bottle2004-08-300000-00-00NoNoCurrent