FDA.reportPublic FDA data

Adult Cough Relief DM

Product NDC
21130-383
11-digit product format
211300383
Labeler code
21130
Product ID
21130-383_155100dc-a514-4896-94f9-a3bbd8fb20ce
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-30
Marketing end
2025-06-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/10mL
Pharmacologic classes
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
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 productproduct21130-383DDiscontinued by firm2026-10-05
excluded packagepackage21130-38321130-383-04DDiscontinued 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 · 4 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 packagepackage21130-383-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21130-383-04f5e01cc5f278…a2eaf40c39c3…

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 INGREDIENT9D2RTI9KYHADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
GLUCOSE OXIDASEINACTIVE INGREDIENT0T8392U5N1ADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-383ADULT COUGH RELIEF DM (DEXTROMETHORPHAN HBR) LIQUID [SAFEWAY, INC.]7Legacy NDC20221110_312749dc-8e60-4cab-9054-e8f04a5e9dfc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-383-04211300383041 BOTTLE, PLASTIC in 1 BOX (21130-383-04) > 118 mL in 1 BOTTLE, PLASTIC2014-06-302025-06-30NoNoCurrent