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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022565-001ADVIL CONGESTION RELIEFIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORALRLD, RS2010-05-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2784e616aacf4f…
2026-08-18 06:07:402026-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273f01610625f2…
2019-09-15 20:21 UTC2019-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1369775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
531abadc-37fd-4953-95bc-a211a2ba6914Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL SINUS CONGESTION AND PAINIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf2025-07-22WarningsExact identifier
application applno (NDA): 022565
application number: NDA022565
Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.531abadc-37fd-4953-95bc-a211a2ba69142023-03-15WarningsExact identifier
application applno (NDA): 022565
application number: NDA022565
ndc (product): 67751-150

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