Advil Sinus Congestion and Pain Relief

Product NDC
67751-150
11-digit product format
677510150
Labeler code
67751
Product ID
67751-150_f6f7501a-9ba4-82ea-e053-6294a90a298e
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
NDA022565
Marketing category
NDA
Marketing start
2016-09-20
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
Advil Sinus Congestion and Pain 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
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-150-01Advil Sinus Congestion and Pain Relief1 in 1 CARTONTABLET, COATED13
67751-150-01Advil Sinus Congestion and Pain Relief1 in 1 POUCHTABLET, COATED13
67751-150-02Advil Sinus Congestion and Pain Relief2 in 1 POUCHTABLET, COATED23
67751-150-02Advil Sinus Congestion and Pain Relief1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-150ADVIL SINUS CONGESTION AND PAIN RELIEF (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]3Current NDC, Legacy NDC, 4 package rows20230316_531abadc-37fd-4953-95bc-a211a2ba6914.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN531abadc-37fd-4953-95bc-a211a2ba69143
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD531abadc-37fd-4953-95bc-a211a2ba69143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-150-01677510150011 POUCH in 1 CARTON (67751-150-01) / 1 TABLET, COATED in 1 POUCH1 pouch2016-09-200000-00-00NoNoCurrent
67751-150-02677510150021 POUCH in 1 CARTON (67751-150-02) / 2 TABLET, COATED in 1 POUCH1 pouch2016-09-200000-00-00NoNoCurrent