FDA.reportPublic FDA data

Endal

Product NDC
50991-136
11-digit product format
509910136
Labeler code
50991
Product ID
50991-136_42678322-4335-74c0-e063-6394a90a77cb
Type
HUMAN OTC DRUG
Nonproprietary name
Triprolidine HCl, Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-22
Substance
DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
10; 1.25 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
Endal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
TRIPROLIDINE HYDROCHLORIDE1.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, YAN7R5L890
Rxcui2637485

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-136-05Endal5 mL in 1 BOTTLELIQUID54
50991-136-15Endal15 mL in 1 BOTTLELIQUID154
50991-136-16Endal473 mL in 1 BOTTLELIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-136-16ML - Milliliter50991-1366c3b1d25-9b9b-45fc-811c-23e2f0c7e36612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-136ENDAL (TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR) LIQUID [POLY PHARMACEUTICALS, INC.]3Current NDC, 3 package rows20240711_fc5401e2-ed65-72e7-e053-6294a90a81f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637485dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG in 5 mL Oral SolutionPSNfc5401e2-ed65-72e7-e053-6294a90a81f34
2637485dextromethorphan hydrobromide 2 MG/ML / triprolidine hydrochloride 0.25 MG/ML Oral SolutionSCDfc5401e2-ed65-72e7-e053-6294a90a81f34
2637485dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG per 5 ML Oral SolutionSYfc5401e2-ed65-72e7-e053-6294a90a81f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50991-136-05509910136055 mL in 1 BOTTLE (50991-136-05) 5 ml2025-10-29NoNoCurrent
50991-136-155099101361515 mL in 1 BOTTLE (50991-136-15) 15 ml2023-05-22NoNoCurrent
50991-136-1650991013616473 mL in 1 BOTTLE (50991-136-16) 473 ml2023-05-22NoNoCurrent