Home NDC 11822-0084 Ibuprofen and Pseudoephedrine Hydrochloride
Product NDC 11822-0084
11-digit product format 118220084
Labeler code 11822
Product ID 11822-0084_61dd37ef-591d-42c8-9bdc-bd2a6073e63b
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Rite-Aid
Application ANDA074567
Marketing category ANDA
Marketing start 2018-02-01
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 · 9 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 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 11822-0084-5 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 11822-0084-6 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 11822-0084-5 e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 11822-0084-6 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 11822-0084-5 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 11822-0084-6 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 11822-0084-5 2022-01-27 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-5 2022-01-27 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-6 2022-01-27 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-6 2022-01-27 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-5 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-5 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-6 2020-01-31 IBUPROFEN & PSEUDOEPHEDRINE HCl TABLETS, USP 11822-0084-6 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 11822-0084-5 Ibuprofen and Pseudoephedrine Hydrochloride 1 in 1 CARTON TABLET, COATED 1 2 11822-0084-5 Ibuprofen and Pseudoephedrine Hydrochloride 20 in 1 BLISTER PACK TABLET, COATED 20 2 11822-0084-6 Ibuprofen and Pseudoephedrine Hydrochloride 1 in 1 CARTON TABLET, COATED 1 2 11822-0084-6 Ibuprofen and Pseudoephedrine Hydrochloride 40 in 1 BLISTER PACK TABLET, COATED 40 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-0084 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [RITE-AID] 2 Current NDC, Legacy NDC, 4 package rows 20220129_483c3bb7-529e-4684-80e1-6646b050988e.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 Units Marketing start Marketing end Sample Exclude flag Status 11822-0084-5 11822008405 1 BLISTER PACK in 1 CARTON (11822-0084-5) / 20 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2018-02-01 0000-00-00 No No Current 11822-0084-6 11822008406 1 BLISTER PACK in 1 CARTON (11822-0084-6) / 40 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2018-02-01 0000-00-00 No No Current