Home NDC 63102-115 ACTIDOM DA
Product NDC 63102-115
11-digit product format 631020115
Labeler code 63102
Product ID 63102-115_e2d0fae5-74da-4a40-8e64-708a3d237ea8
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Phenylephrine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ACTIPHARMA, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-20
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1; 2.5 mg/5mL; mg/5mL
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ACTIDOM DA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 1 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1429345 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63102-115-16 ACTIDOM DA 474 mL in 1 BOTTLE, PLASTIC SOLUTION 474 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63102-115 ACTIDOM DA (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240809_7797c22e-ffeb-4798-9fb6-aa64cf077ba7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 174 of 174 · 3,464 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 Warnings Exact identifier application number: M012 Chlorpheniramine maleate 4mg CHLORPHENIRAMINE MALEATE 4MG Athlete's Needs, Inc. 4d974959-25fc-4707-9b72-9afbf47b76f1 2017-11-14 Warnings Exact identifier application number: M012 Cold Medicine ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL Selder, S.A. de C.V. d2762d9c-e7e7-42b2-a26a-14b2aa0307cb 2017-01-25 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Marc Glassman, Inc. 2051247f-ce64-4cf5-b449-9ca14c43ab86 2016-12-27 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63102-115-16 63102011516 474 mL in 1 BOTTLE, PLASTIC (63102-115-16) 474 ml 2022-01-20 0000-00-00 No No Current