FDA.reportPublic FDA data

ALA-HIST IR

Product NDC
50991-783
11-digit product format
509910783
Labeler code
50991
Product ID
50991-783_4513db4f-e8f2-ecc6-e063-6294a90a1b17
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Poly Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-22
Substance
DEXBROMPHENIRAMINE MALEATE
Active strength
2 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALA-HIST IR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBPA9UT29BS
Rxcui2262293, 2262295

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-783-02ALA-HIST IR1 in 1 BLISTER PACKTABLET111
50991-783-02ALA-HIST IR12 in 1 CARTONTABLET1211
50991-783-60ALA-HIST IR60 in 1 BOTTLE, PLASTICTABLET6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-783-60EA - Each50991-7839c42708d-fac3-4149-b21e-c6e82426a3d412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-783ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 3 package rows20240711_0d203b5c-8b10-428b-8703-17be6b4ce6eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2262295ALA-HIST IR 2 MG Oral TabletPSN0d203b5c-8b10-428b-8703-17be6b4ce6eb11
2262293dexbrompheniramine maleate 2 MG Oral TabletPSN0d203b5c-8b10-428b-8703-17be6b4ce6eb11
2262295dexbrompheniramine maleate 2 MG Oral Tablet [Ala-Hist IR]SBD0d203b5c-8b10-428b-8703-17be6b4ce6eb11
2262293dexbrompheniramine maleate 2 MG Oral TabletSCD0d203b5c-8b10-428b-8703-17be6b4ce6eb11
2262295Ala-Hist IR (dexbrompheniramine maleate 2 MG) Oral TabletSY0d203b5c-8b10-428b-8703-17be6b4ce6eb11
2262295Ala-Hist IR 2 MG Oral TabletSY0d203b5c-8b10-428b-8703-17be6b4ce6eb11
2262295AlaHist IR 2 MG Oral TabletSY0d203b5c-8b10-428b-8703-17be6b4ce6eb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50991-783-025099107830212 BLISTER PACK in 1 CARTON (50991-783-02) / 1 TABLET in 1 BLISTER PACK12 blister pack2011-08-220000-00-00NoNoCurrent
50991-783-605099107836060 TABLET in 1 BOTTLE, PLASTIC (50991-783-60) 60 tablet2011-08-220000-00-00NoNoCurrent