Dextromethorphan HBr 15 mg Liquid Gels

Product NDC
0536-1334
11-digit product format
005361334
Labeler code
0536
Product ID
0536-1334_4d5e303a-af93-4c41-bced-c1041240fe65
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dextromethorphan HBr 15 mg Liquid Gels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090487

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1334-34Dextromethorphan HBr 15 mg Liquid Gels20 in 1 BOTTLECAPSULE, LIQUID FILLED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1334-34EA - Each0536-13349b2bf7f7-7261-4284-bc60-22b3f2ed825812022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1334DEXTROMETHORPHAN HBR 15 MG LIQUID GELS (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES]4Current NDC, Legacy NDC, 1 package rows20250101_cf3cc387-6642-43fd-999d-688fdaf65d4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSNcf3cc387-6642-43fd-999d-688fdaf65d4f4
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCDcf3cc387-6642-43fd-999d-688fdaf65d4f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1334-340053613343420 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1334-34) 2021-09-040000-00-00NoNoCurrent