ACTICON

Product NDC
63102-108
11-digit product format
631020108
Labeler code
63102
Product ID
63102-108_5bfc3584-960d-4fde-a4ea-03b3c9eb0293
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ACTIPHARMA, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-15
Substance
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 60 mg/5mL; mg/5mL
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
ACTICON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXBROMPHENIRAMINE MALEATE2 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBPA9UT29BS, 6V9V2RYJ8N
Rxcui2592643

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
63102-108-16ACTICON474 mL in 1 BOTTLE, PLASTICSOLUTION4743

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63102-108ACTICON (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20240814_aea0335d-75e6-4a90-86a5-f197cf024a11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2592643dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG in 5 mL Oral SolutionPSNaea0335d-75e6-4a90-86a5-f197cf024a113
2592643dexbrompheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 12 MG/ML Oral SolutionSCDaea0335d-75e6-4a90-86a5-f197cf024a113
2592643dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG per 5 ML Oral SolutionSYaea0335d-75e6-4a90-86a5-f197cf024a113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63102-108-1663102010816474 mL in 1 BOTTLE, PLASTIC (63102-108-16) 474 ml2022-02-150000-00-00NoNoCurrent