FDA.reportPublic FDA data

Capron DM

Product NDC
29978-127
11-digit product format
299780127
Labeler code
29978
Product ID
29978-127_37da30a9-c2bd-ea24-e063-6294a90a6e8a
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Pyrilamine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
Capital Pharmaceutical, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-20
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength
7.5; 7.5 mg/5mL; 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
Capron DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/5mL
PYRILAMINE MALEATE7.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, R35D29L3ZA
Rxcui1423307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29978-127-152025-06-20C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-162025-06-20C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-152024-07-30C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-162024-07-30C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-152024-01-30C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-162024-01-30C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-152020-03-12C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-162020-03-12C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-152020-01-31C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid
29978-127-162020-01-31C16284748780-19d75b9cf-f203-f424-e053-dadaa90a57ceCapron DM Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-127-15Capron DM15 mL in 1 BOTTLELIQUID159
29978-127-15Capron DM6 in 1 BOXLIQUID69
29978-127-16Capron DM473 mL in 1 BOTTLELIQUID4739
29978-127-16Capron DM1 in 1 BOXLIQUID19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29978-127-16ML - Milliliter29978-12796211107-5c26-4760-b878-5761d2631c6912013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZACAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PYRILAMINEACTIVE MOIETYHPE317O9TLCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29978-127CAPRON DM (DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]8Current NDC, Legacy NDC, 4 package rows20230111_cf778c5f-475e-4a86-a87c-2be1e665f5a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1423307dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral SolutionPSNcf778c5f-475e-4a86-a87c-2be1e665f5a59
1423307dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral SolutionSCDcf778c5f-475e-4a86-a87c-2be1e665f5a59
1423307dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral SolutionSYcf778c5f-475e-4a86-a87c-2be1e665f5a59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29978-127-15299780127156 BOTTLE in 1 BOX (29978-127-15) / 15 mL in 1 BOTTLE6 bottle2013-06-200000-00-00NoNoCurrent
29978-127-16299780127161 BOTTLE in 1 BOX (29978-127-16) / 473 mL in 1 BOTTLE1 bottle2013-06-200000-00-00NoNoCurrent