Equaline congestion relief

Product NDC
41163-158
11-digit product format
411630158
Labeler code
41163
Product ID
41163-158_dce4f370-16bd-4192-ab5c-bd74632c1c25
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen, phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA203200
Marketing category
ANDA
Marketing start
2015-07-17
Substance
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [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 congestion relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM, 04JA59TNSJ
Rxcui1369775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-158-46Equaline congestion relief10 in 1 CARTONTABLET, FILM COATED105
41163-158-46Equaline congestion relief1 in 1 BLISTER PACKTABLET, FILM COATED15
41163-158-60Equaline congestion relief20 in 1 CARTONTABLET, FILM COATED205
41163-158-60Equaline congestion relief1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-158-46EA - Each41163-1581cdae6bd-ec6d-4c62-9303-a8b899397ec112017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-158EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]5Current NDC, Legacy NDC, 4 package rows20230809_06dcece5-0fdc-4ff1-a8b1-fadb503a9f50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN06dcece5-0fdc-4ff1-a8b1-fadb503a9f505
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD06dcece5-0fdc-4ff1-a8b1-fadb503a9f505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-158-464116301584610 BLISTER PACK in 1 CARTON (41163-158-46) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-07-170000-00-00NoNoCurrent
41163-158-604116301586020 BLISTER PACK in 1 CARTON (41163-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK20 blister pack2021-03-080000-00-00NoNoCurrent