Home NDC 0573-0184 ADVIL COLD AND SINUS
Product NDC 0573-0184
11-digit product format 005730184
Labeler code 0573
Product ID 0573-0184_57c53749-0be1-d204-e063-6394a90a2704
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen, pseudoephedrine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Haleon US Holdings LLC
Application NDA021374
Marketing category NDA
Marketing start 2002-05-30
Substance IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 200; 30 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021374-001 ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30
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 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021374-001 ADVIL COLD AND SINUS EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE / ORAL RLD, RS 2002-05-30 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 COLD AND SINUS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE 30 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 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299018 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 0573-0184-16 ADVIL COLD AND SINUS 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 13 0573-0184-16 ADVIL COLD AND SINUS 16 in 1 CARTON CAPSULE, LIQUID FILLED 16 13 0573-0184-32 ADVIL COLD AND SINUS 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 13 0573-0184-32 ADVIL COLD AND SINUS 32 in 1 CARTON CAPSULE, LIQUID FILLED 32 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ibuprofen ACTIVE INGREDIENT WK2XYI10QM ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 pseudoephedrine hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 ibuprofen ACTIVE MOIETY WK2XYI10QM ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 coconut acid INACTIVE INGREDIENT 40U37V505D ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 gelatin INACTIVE INGREDIENT 2G86QN327L ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 sorbitan INACTIVE INGREDIENT 6O92ICV9RU ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 sorbitol INACTIVE INGREDIENT 506T60A25R ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4 water INACTIVE INGREDIENT 059QF0KO0R ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0184 ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] 12 Current NDC, Legacy NDC, 4 package rows 20240622_0da9ed22-bfb4-d61b-110b-0c7760332a98.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 · 1 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 0573-0184-16 00573018416 16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 16 blister pack 2002-05-30 0000-00-00 No No Current 0573-0184-32 00573018432 32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 32 blister pack 2002-05-30 0000-00-00 No No Current