Home NDC 41163-158 Equaline congestion relief
Product NDC 41163-158
11-digit product format 411630158
Labeler code 41163
Product ID 41163-158_dce4f370-16bd-4192-ab5c-bd74632c1c25
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen, phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application ANDA203200
Marketing category ANDA
Marketing start 2015-07-17
Substance IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 200; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03
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 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Equaline congestion relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 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 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369775 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 41163-158-46 Equaline congestion relief 10 in 1 CARTON TABLET, FILM COATED 10 5 41163-158-46 Equaline congestion relief 1 in 1 BLISTER PACK TABLET, FILM COATED 1 5 41163-158-60 Equaline congestion relief 20 in 1 CARTON TABLET, FILM COATED 20 5 41163-158-60 Equaline congestion relief 1 in 1 BLISTER PACK TABLET, FILM COATED 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-158 EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI] 5 Current NDC, Legacy NDC, 4 package rows 20230809_06dcece5-0fdc-4ff1-a8b1-fadb503a9f50.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 · 3 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 41163-158-46 41163015846 10 BLISTER PACK in 1 CARTON (41163-158-46) > 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2015-07-17 0000-00-00 No No Current 41163-158-60 41163015860 20 BLISTER PACK in 1 CARTON (41163-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK 20 blister pack 2021-03-08 0000-00-00 No No Current