Home NDC 0573-2160 ADVIL COLD AND SINUS
Product NDC 0573-2160
11-digit product format 005732160
Labeler code 0573
Product ID 0573-2160_cec76100-19bc-49c3-8805-7badb2a8bf28
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen and pseudoephedrine hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Haleon US Holdings LLC
Application NDA019771
Marketing category NDA
Marketing start 2018-01-01
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 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 N019771-001 ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19
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 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019771-001 ADVIL COLD AND SINUS 200MG;30MG TABLET / ORAL RLD, RS 1989-09-19 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 2026-12-31 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 1299021 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-2160-74 ADVIL COLD AND SINUS 4 in 1 CARTON TABLET, COATED 4 16 0573-2160-74 ADVIL COLD AND SINUS 2 in 1 PACKAGE TABLET, COATED 2 16
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) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 pseudoephedrine hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 ibuprofen ACTIVE MOIETY WK2XYI10QM ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 POVIDONE INACTIVE INGREDIENT FZ989GH94E ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ADVIL COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HCL) TABLET, COATED [PFIZER CONSUMER HEALTHCARE] 7
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 Sample Exclude flag Status 0573-2160-74 00573216074 2 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK 2 carton 2018-01-01 No No Current