Home NDC 0904-5817 Cough and Cold
Product NDC 0904-5817
11-digit product format 009045817
Labeler code 0904
Product ID 0904-5817_7ede4f64-d5c5-4743-97b8-81b8ab4abf4d
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Major Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2003-05-03
Marketing end 2020-03-31
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 4 mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 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 0904-5817-44 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 ACACIA INACTIVE INGREDIENT 5C5403N26O COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 LACTOSE INACTIVE INGREDIENT J2B2A4N98G COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 SHELLAC INACTIVE INGREDIENT 46N107B71O COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [MAJOR PHARMACEUTICALS] 5