Home NDC 0536-4391 Nasal Decongestant
Product NDC 0536-4391
11-digit product format 005364391
Labeler code 0536
Product ID 0536-4391_26ba1486-871c-47fa-9790-328a9d3bdf5d
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Rugby Laboratories, Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-09-22
Marketing end 0000-00-00
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1
NDC exclude flag E
Listing certified through 2018-12-31
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 · 24 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 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 0536-4391-35 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 CALCIUM SULFATE ANHYDROUS INACTIVE INGREDIENT E934B3V59H NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [RUGBY LABORATORIES, INC] 1