Home NDC 0485-0210-01 ED-A-HIST PSE
Product NDC 0485-0210
Requested package NDC 0485-0210-01
11-digit product format 004850210
Labeler code 0485
Product ID 0485-0210_d57f830b-52d0-0fd2-e053-2995a90a8a7a
Type HUMAN OTC DRUG
Nonproprietary name PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler EDWARDS PHARMACEUTICALS, INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-10-08
Marketing end 0000-00-00
Substance PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength 60 mg/1; mg/1
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0485-0210-01 ED-A-HIST PSE 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 TRIPROLIDINE HYDROCHLORIDE ACTIVE INGREDIENT YAN7R5L890 ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 TRIPROLIDINE ACTIVE MOIETY 2L8T9S52QM ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0485-0210 ED-A-HIST PSE (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 4 Legacy NDC, 1 package rows 20220114_b0c6ef78-0f82-4ff7-a988-b11f99094843.zip
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 0485-0210-01 00485021001 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) 2011-10-08 0000-00-00 No No Current