Home NDC 69168-406 Cold and Allergy
Product NDC 69168-406
11-digit product format 691680406
Labeler code 69168
Product ID 69168-406_6a26079c-017d-4117-9dbe-cb9e7fa7c86e
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl and Chlorpheniramine maleate
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-23
Substance PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength 10; 4 mg/1; mg/1
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 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 Cold and Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 CHLORPHENIRAMINE MALEATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090443 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 69168-406-93 Cold and Allergy 24 in 1 BLISTER PACK TABLET 24 3 69168-406-93 Cold and Allergy 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-406 COLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH] 3 Current NDC, Legacy NDC, 2 package rows 20231115_7af63769-fa56-4f1f-a2ad-5b4c108c8e4f.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 74 of 180 · 3,583 matching rows.
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 69168-406-93 69168040693 1 BLISTER PACK in 1 CARTON (69168-406-93) / 24 TABLET in 1 BLISTER PACK 1 blister pack 2014-12-23 0000-00-00 No No Current