Home NDC 0573-0199 ADVIL SINUS CONGESTION AND PAIN
Product NDC 0573-0199
11-digit product format 005730199
Labeler code 0573
Product ID 0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen, phenylephrine hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application NDA022565
Marketing category NDA
Marketing start 2015-07-01
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022565-001 ADVIL CONGESTION RELIEF IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022565-001 ADVIL CONGESTION RELIEF 200MG;10MG TABLET / ORAL RLD, RS 2010-05-27 f41ea6bd6efb…
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-0199-01 ADVIL SINUS CONGESTION AND PAIN 50 in 1 TRAY TABLET, COATED 50 15 0573-0199-01 ADVIL SINUS CONGESTION AND PAIN 1 in 1 POUCH TABLET, COATED 1 15 0573-0199-03 ADVIL SINUS CONGESTION AND PAIN 1 in 1 POUCH TABLET, COATED 1 15 0573-0199-03 ADVIL SINUS CONGESTION AND PAIN 3000 in 1 CARTON TABLET, COATED 3000 15 0573-0199-11 ADVIL SINUS CONGESTION AND PAIN 10 in 1 CARTON TABLET, COATED 10 15 0573-0199-11 ADVIL SINUS CONGESTION AND PAIN 1 in 1 BLISTER PACK TABLET, COATED 1 15 0573-0199-21 ADVIL SINUS CONGESTION AND PAIN 1 in 1 BLISTER PACK TABLET, COATED 1 15 0573-0199-21 ADVIL SINUS CONGESTION AND PAIN 20 in 1 CARTON TABLET, COATED 20 15 0573-0199-22 ADVIL SINUS CONGESTION AND PAIN 30 in 1 CARTON TABLET, COATED 30 15 0573-0199-22 ADVIL SINUS CONGESTION AND PAIN 1 in 1 BLISTER PACK TABLET, COATED 1 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 IBUPROFEN ACTIVE MOIETY WK2XYI10QM ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 EGG PHOSPHOLIPIDS INACTIVE INGREDIENT 1Z74184RGV ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0199 ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC] 13 Current NDC, Legacy NDC, 10 package rows 20250316_b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0573-0199-01 00573019901 50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH 50 pouch 2015-07-01 0000-00-00 No No Current 0573-0199-03 00573019903 3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH 3000 pouch 2015-07-01 0000-00-00 No No Current 0573-0199-11 00573019911 10 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACK 10 blister pack 2015-07-01 0000-00-00 No No Current 0573-0199-21 00573019921 20 BLISTER PACK in 1 CARTON (0573-0199-21) / 1 TABLET, COATED in 1 BLISTER PACK 20 blister pack 2015-07-01 0000-00-00 No No Current 0573-0199-22 00573019922 30 BLISTER PACK in 1 CARTON (0573-0199-22) / 1 TABLET, COATED in 1 BLISTER PACK 30 blister pack 2015-11-02 0000-00-00 No No Current