FDA.reportPublic FDA data

DELSYM

Product NDC
50090-0224
11-digit product format
500900224
Labeler code
50090
Product ID
50090-0224_018b0d50-2f6c-447a-a3bc-f43f639834b1
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018658
Marketing category
NDA
Marketing start
2010-05-04
Substance
DEXTROMETHORPHAN
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DELSYM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7355X3ROTS
Rxcui1373045, 1373128

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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0224-0DELSYM89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE8919
50090-0224-0DELSYM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0224-0ML - Milliliter50090-02243c7a605b-048c-4053-87e1-e34dda64bec612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0224DELSYM (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 2 package rows20250302_2ac3cac7-5980-4ff5-9939-d494c3daa9d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN2ac3cac7-5980-4ff5-9939-d494c3daa9d219
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN2ac3cac7-5980-4ff5-9939-d494c3daa9d219
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD2ac3cac7-5980-4ff5-9939-d494c3daa9d219
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD2ac3cac7-5980-4ff5-9939-d494c3daa9d219
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY2ac3cac7-5980-4ff5-9939-d494c3daa9d219
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY2ac3cac7-5980-4ff5-9939-d494c3daa9d219
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY2ac3cac7-5980-4ff5-9939-d494c3daa9d219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0224-0500900224001 BOTTLE in 1 CARTON (50090-0224-0) / 89 mL in 1 BOTTLE1 bottle2014-11-280000-00-00NoNoCurrent