adult cough suppressant dextromethorphan HBr

Product NDC
0536-1480
11-digit product format
005361480
Labeler code
0536
Product ID
0536-1480_74b1edaf-4f01-4a00-a270-ee539bdac0ab
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rugby Laboratories
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-08
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/1
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cough Suppressant
Brand name suffix
Adult
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH

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
0536-1480-34adult cough suppressant dextromethorphan HBr20 in 1 BOTTLECAPSULE, LIQUID FILLED202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0536-1480-340053614803420 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1480-34) 2026-05-08NoNoHistorical