FDA.reportPublic FDA data

Cough DM

Product NDC
11822-0494
11-digit product format
118220494
Labeler code
11822
Product ID
11822-0494_320b3471-a22c-4be8-b640-36d46c66c244
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA091135
Marketing category
ANDA
Marketing start
2015-07-06
Marketing end
2026-09-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cough DM

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0494-1Cough DM89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE895
11822-0494-1Cough DM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE15
11822-0494-2Cough DM148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1485
11822-0494-2Cough DM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0494COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RITE AID CORPORATION]4Current NDC, Legacy NDC, 4 package rows20230219_0b92c230-e86f-4e2f-9330-6a85de61eaf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN0b92c230-e86f-4e2f-9330-6a85de61eaf05
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD0b92c230-e86f-4e2f-9330-6a85de61eaf05
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY0b92c230-e86f-4e2f-9330-6a85de61eaf05
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY0b92c230-e86f-4e2f-9330-6a85de61eaf05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0494-1118220494011 BOTTLE in 1 CARTON (11822-0494-1) / 89 mL in 1 BOTTLE1 bottle2015-07-062026-06-01NoNoCurrent
11822-0494-2118220494021 BOTTLE in 1 CARTON (11822-0494-2) / 148 mL in 1 BOTTLE1 bottle2022-07-212026-09-01NoNoHistorical