FDA.reportPublic FDA data

BRONCOCHEM

Product NDC
65131-098
11-digit product format
651310098
Labeler code
65131
Product ID
65131-098_8ddc705a-c6b4-4b03-8492-d2b00eaa4b88
Type
HUMAN OTC DRUG
Nonproprietary name
Cholpheniramine maleate-Phenylephrine HCl
Dosage form
SYRUP
Route
ORAL
Labeler
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-04-01
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4; 10 mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 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
BRONCOCHEM
Brand name suffix
ALLERGY CONTROL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 04JA59TNSJ
Rxcui1876117

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-098-47BRONCOCHEMALLERGY CONTROL1 in 1 BOXSYRUP11
65131-098-47BRONCOCHEMALLERGY CONTROL120 mL in 1 BOTTLE, PLASTICSYRUP1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-098BRONCOCHEM ALLERGY CONTROL (CHOLPHENIRAMINE MALEATE-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1Current NDC, Legacy NDC, 2 package rows20170401_ec5a216c-6827-4de3-8683-ff04e726ff6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1876117chlorpheniramine maleate 0.4 MG/mL / phenylephrine HCl 1 MG/mL Oral SolutionPSNec5a216c-6827-4de3-8683-ff04e726ff6f1
1876117chlorpheniramine maleate 0.4 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDec5a216c-6827-4de3-8683-ff04e726ff6f1
1876117chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYec5a216c-6827-4de3-8683-ff04e726ff6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65131-098-47651310098471 BOTTLE, PLASTIC in 1 BOX (65131-098-47) / 120 mL in 1 BOTTLE, PLASTIC2017-04-010000-00-00NoNoCurrent