Cough

Product NDC
11822-0419
Requested package NDC
11822-0419-1
11-digit product format
118220419
Labeler code
11822
Product ID
11822-0419_cbe93643-8c47-4ba3-a8fa-f89a73a8020f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-08-16
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-041911822-0419-1DDiscontinued by firm2026-10-21

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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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 INGREDIENT9D2RTI9KYHCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
GUAIFENESINACTIVE MOIETY495W7451VQCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9COUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH CHILDRENS MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RITE AID CORPORATION]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0419-1118220419011 BOTTLE in 1 CARTON (11822-0419-1) > 118 mL in 1 BOTTLE1 bottle2007-08-160000-00-00NoNoCurrent