FDA.reportPublic FDA data

Capron DMT

Product NDC
29978-128
11-digit product format
299780128
Labeler code
29978
Product ID
29978-128_45a51318-64ac-dfca-e063-6394a90ab66e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Pyrilamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Capital Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-01-26
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength
30; 30 mg/1; 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
Capron DMT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
PYRILAMINE MALEATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, R35D29L3ZA
Rxcui1923362

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29978-128-102025-12-03C16284748780-19d75b9d0-af4e-f424-e053-dadaa90a57ceCapron DMT Tablets
29978-128-102025-07-29C16284748780-19d75b9d0-af4e-f424-e053-dadaa90a57ceCapron DMT Tablets
29978-128-102020-03-12C16284748780-19d75b9d0-af4e-f424-e053-dadaa90a57ceCapron DMT Tablets
29978-128-102020-01-31C16284748780-19d75b9d0-af4e-f424-e053-dadaa90a57ceCapron DMT Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-128-10Capron DMT100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29978-128CAPRON DMT (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) TABLET [CAPITAL PHARMA]4Current NDC, Legacy NDC, 1 package rows20241201_50222df4-5c31-1304-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923362dextromethorphan HBr 30 MG / pyrilamine maleate 30 MG Oral TabletPSN50222df4-5c31-1304-e054-00144ff88e886
1923362dextromethorphan hydrobromide 30 MG / pyrilamine maleate 30 MG Oral TabletSCD50222df4-5c31-1304-e054-00144ff88e886
1923362dextromethorphan HBr 30 MG / pyrilamine maleate 30 MG Oral TabletSY50222df4-5c31-1304-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29978-128-1029978012810100 TABLET in 1 BOTTLE, PLASTIC (29978-128-10) 100 tablet2017-01-260000-00-00NoNoCurrent