FDA.reportPublic FDA data

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC
0574-1104
11-digit product format
005741104
Labeler code
0574
Product ID
0574-1104_aa6625e1-c78d-417a-bdf3-fc09a5b26966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA205292
Marketing category
ANDA
Marketing start
2015-02-06
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 10; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH, 6V9V2RYJ8N
Rxcui1357010

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-1104-04Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide118 mL in 1 BOTTLE, PLASTICSYRUP1186
0574-1104-16Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide473 mL in 1 BOTTLE, PLASTICSYRUP4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-1104-04ML - Milliliter0574-11042be4169a-7708-46e0-a135-18cd96ec76c312015-03-03
0574-1104-16ML - Milliliter0574-1104efa07042-0a77-4257-84d5-c6aef68af2f712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADDOCK LABORATORIES, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-1104BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PADAGIS US LLC]5Current NDC, Legacy NDC, 2 package rows20230329_06db369d-09fe-4ca2-b98c-705356b7c403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN85b98fa3-376c-41a3-b3c1-0c739d903a22104
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN4368822d-2779-4fb2-9ca9-f020b8934dc5104
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD85b98fa3-376c-41a3-b3c1-0c739d903a22104
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD4368822d-2779-4fb2-9ca9-f020b8934dc5104
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY85b98fa3-376c-41a3-b3c1-0c739d903a22104
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY4368822d-2779-4fb2-9ca9-f020b8934dc5104
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN51c95c28-8979-4b75-b1d6-856875106587102
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD51c95c28-8979-4b75-b1d6-856875106587102
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY51c95c28-8979-4b75-b1d6-856875106587102
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN06db369d-09fe-4ca2-b98c-705356b7c4036
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD06db369d-09fe-4ca2-b98c-705356b7c4036
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY06db369d-09fe-4ca2-b98c-705356b7c4036
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN440d0554-995c-47df-b9f6-f3e3ce2e35e05
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD440d0554-995c-47df-b9f6-f3e3ce2e35e05
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY440d0554-995c-47df-b9f6-f3e3ce2e35e05
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN35236e4a-6e98-4c4d-85bf-7551fd08d7004
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD35236e4a-6e98-4c4d-85bf-7551fd08d7004
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY35236e4a-6e98-4c4d-85bf-7551fd08d7004
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSNed9399e2-2be8-4793-99c5-204779c2a4713
1357010brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCDed9399e2-2be8-4793-99c5-204779c2a4713
1357010brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSYed9399e2-2be8-4793-99c5-204779c2a4713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-1104-0400574110404118 mL in 1 BOTTLE, PLASTIC (0574-1104-04) 118 ml2015-02-060000-00-00NoNoCurrent
0574-1104-1600574110416473 mL in 1 BOTTLE, PLASTIC (0574-1104-16) 473 ml2015-02-060000-00-00NoNoCurrent