Tussin Peak Cold sugar-free COUGH PLUS CHEST CONGESTION DM

Product NDC
53943-023
11-digit product format
539430023
Labeler code
53943
Product ID
53943-023_7be3a200-924c-4509-9dba-eda7b3e0c6bd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-21
Marketing end
2022-05-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
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 productproduct53943-023DDiscontinued by firm2026-10-05
excluded packagepackage53943-02353943-023-20DDiscontinued by firm2026-10-05

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 packagepackage53943-023-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53943-023-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53943-023-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53943-023-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53943-023-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53943-023-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53943-023-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53943-023-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53943-023-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53943-023-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53943-023-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53943-023-20557ba5c1ecfa…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
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
CHERRYINACTIVE INGREDIENTBUC5I9595WTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)INACTIVE INGREDIENTM825OX60H9TUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
LEVOMENTHOLINACTIVE INGREDIENTBZ1R15MTK7TUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
VANILLAINACTIVE INGREDIENTQ74T35078HTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-023-20539430023201 BOTTLE in 1 CARTON (53943-023-20) > 237 mL in 1 BOTTLE1 bottle2015-04-212022-05-01NoNoCurrent