Cough and Cold HBP

Product NDC
50844-411
11-digit product format
508440411
Labeler code
50844
Product ID
50844-411_64efd360-f5a5-4713-a979-2f08ca5ba691
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-05-03
Marketing end
2020-01-16
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50844-411DDiscontinued by firm2026-10-16
excluded packagepackage50844-41150844-411-21DDiscontinued by firm2026-10-16

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50844-411-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50844-411-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50844-411-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50844-411-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50844-411-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50844-411-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50844-411-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50844-411-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50844-411-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50844-411-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50844-411-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50844-411-21557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOUGH AND COLD RELIEF HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, SUGAR COATED [L.N.K. INTERNATIONAL, INC.]2