FDA.reportPublic FDA data

Balahist

Product NDC
63162-520
11-digit product format
631620520
Labeler code
63162
Product ID
63162-520_da947d56-e0f5-4f91-88bd-82990cd4a7c4
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
Ballay Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-06
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
4 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63162-520-162019-11-27C16284748780-19855e2a2-3a8f-60a7-e053-dbdaa90a05bdBalahist DM Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63162-520-16BalahistDM Syrup473 mL in 1 BOTTLELIQUID4731

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03BALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63162-520BALAHIST DM SYRUP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BALLAY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20140106_3434547a-6ef1-496f-93a2-e1c0539ebaaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486964brompheniramine maleate 4 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 7.5 MG in 5 mL Oral SolutionPSN3434547a-6ef1-496f-93a2-e1c0539ebaaa1
1486964brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD3434547a-6ef1-496f-93a2-e1c0539ebaaa1
1486964brompheniramine maleate 4 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 7.5 MG per 5 ML Oral SolutionSY3434547a-6ef1-496f-93a2-e1c0539ebaaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63162-520-1663162052016473 mL in 1 BOTTLE473 mlHistorical