FDA.reportPublic FDA data

Durahist

Product NDC
50991-865
11-digit product format
509910865
Labeler code
50991
Product ID
50991-865_472deea6-1315-b265-e063-6394a90a0e34
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Pseudoephedrine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-22
Substance
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Durahist
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBPA9UT29BS, 6V9V2RYJ8N
Rxcui1363513

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-865-02Durahist12 in 1 BLISTER PACKTABLET123
50991-865-90Durahist90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-865-90EA - Each50991-8658791c7a2-1631-4d24-a90c-b348dd0e3db812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-865DURAHIST (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250503_33d71863-5cac-669f-e063-6394a90a6f21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN33d71863-5cac-669f-e063-6394a90a6f213
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD33d71863-5cac-669f-e063-6394a90a6f213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50991-865-025099108650212 TABLET in 1 BLISTER PACK (50991-865-02) 12 tablet2025-12-29NoNoCurrent
50991-865-905099108659090 TABLET in 1 BOTTLE, PLASTIC (50991-865-90) 90 tablet2025-04-22NoNoCurrent