Home NDC 56062-423-21 Ibuprofen and Pseudoephedrine Hydrochloride
Product NDC 56062-423
Requested package NDC 56062-423-21
11-digit product format 560620423
Labeler code 56062
Product ID 56062-423_645177a7-1d43-439b-9e23-75d5a7822d98
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Publix Super Markets Inc
Application ANDA074567
Marketing category ANDA
Marketing start 2001-10-13
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 56062-423-21 Ibuprofen and Pseudoephedrine Hydrochloride 20 in 1 BLISTER PACK TABLET, SUGAR COATED 20 3 56062-423-41 Ibuprofen and Pseudoephedrine Hydrochloride 40 in 1 BLISTER PACK TABLET, SUGAR COATED 40 3
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 [PUBLIX SUPER MARKETS INC] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 GUAR GUM INACTIVE INGREDIENT E89I1637KE IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 TRISTEARIN INACTIVE INGREDIENT P6OCJ2551R IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56062-423 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [PUBLIX SUPER MARKETS INC] 3 Current NDC, Legacy NDC, 2 package rows 20181025_2b98a62b-bd92-4fb8-ad0f-521cb477b612.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 56062-423-21 56062042321 20 TABLET, SUGAR COATED in 1 BLISTER PACK (56062-423-21) 2001-10-13 0000-00-00 No No Current