Home NDC 41250-423 Ibuprofen and Pseudoephedrine Hydrochloride
Product NDC 41250-423
11-digit product format 412500423
Labeler code 41250
Product ID 41250-423_ea96cb21-dc4c-4cca-bb6d-d08e59e08c27
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Meijer Distribution, Inc
Application ANDA074567
Marketing category ANDA
Marketing start 2001-10-13
Marketing end 0000-00-00
Substance IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 200 mg/1; mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 41250-423-40 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 41250-423-40 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 41250-423-40 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 41250-423-40 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 41250-423-40 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 41250-423-40 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 41250-423-40 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 41250-423-40 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 41250-423-40 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 41250-423-40 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 41250-423-40 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 41250-423-40 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 41250-423-40 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 41250-423-40 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 41250-423-40 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 41250-423-40 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 41250-423-40 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 41250-423-40 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 41250-423-40 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 41250-423-40 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 41250-423-40 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…
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 41250-423-40 Ibuprofen and Pseudoephedrine Hydrochloride 40 in 1 BLISTER PACK TABLET, SUGAR COATED 40 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 GUAR GUM INACTIVE INGREDIENT E89I1637KE IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 TRISTEARIN INACTIVE INGREDIENT P6OCJ2551R IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-423 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [MEIJER DISTRIBUTION, INC] 1 Legacy NDC, 1 package rows 20130228_cabd7e2b-c7ef-4557-a98d-f486abc82db3.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 Status 41250-423-40 41250042340 40 in 1 BLISTER PACK Historical