Care One Chest Congestion Relief

Product NDC
10956-014
11-digit product format
109560014
Labeler code
10956
Product ID
10956-014_b4f01c8b-99ed-44d8-ac49-b6187b2b2c95
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reese Pharmaceutical Co
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-12-07
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct10956-014DDiscontinued by firm2026-10-12
excluded packagepackage10956-01410956-014-01DDiscontinued by firm2026-10-12

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 packagepackage10956-014-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10956-014-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10956-014-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10956-014-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10956-014-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10956-014-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10956-014-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10956-014-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10956-014-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10956-014-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10956-014-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10956-014-01557ba5c1ecfa…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 INGREDIENT9D2RTI9KYHCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
GuaifenesinACTIVE INGREDIENT495W7451VQCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
GuaifenesinACTIVE MOIETY495W7451VQCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4CARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARE ONE CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10956-014-01109560014011 BOTTLE, PLASTIC in 1 CARTON (10956-014-01) > 50 TABLET in 1 BOTTLE, PLASTIC (10956-014-50) 2011-01-170000-00-00NoNoCurrent