Home NDC 0363-0423 Ibuprofen and Pseudoephedrine Hydrochloride
Product NDC 0363-0423
11-digit product format 003630423
Labeler code 0363
Product ID 0363-0423_28d9145e-3aa3-4a6e-97d4-591a5ff16be9
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler WALGREEN COMPANY
Application ANDA074567
Marketing category ANDA
Marketing start 2017-08-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 0363-0423 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0363-0423 0363-0423-21 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0363-0423 0363-0423-41 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A074567-001 IBUPROHM COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2001-04-17
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074567-001 IBUPROHM COLD AND SINUS 200MG;30MG TABLET / ORAL 2001-04-17 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen and Pseudoephedrine Hydrochloride
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0363-0423-21 2020-06-18 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-21 2020-06-18 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-41 2020-06-18 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-41 2020-06-18 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-21 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-21 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-41 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 0363-0423-41 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0423-21 Ibuprofen and Pseudoephedrine Hydrochloride 20 in 1 BLISTER PACK TABLET, COATED 20 4 0363-0423-41 Ibuprofen and Pseudoephedrine Hydrochloride 40 in 1 BLISTER PACK TABLET, COATED 40 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 GUAR GUM INACTIVE INGREDIENT E89I1637KE IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 TRISTEARIN INACTIVE INGREDIENT P6OCJ2551R IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0423 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [WALGREEN COMPANY] 4 Current NDC, Legacy NDC, 2 package rows 20221013_c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0.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 · 9 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0363-0423-21 00363042321 20 TABLET, COATED in 1 BLISTER PACK (0363-0423-21) 2017-08-01 0000-00-00 No No Current 0363-0423-41 00363042341 40 TABLET, COATED in 1 BLISTER PACK (0363-0423-41) 2017-08-01 0000-00-00 No No Current