Home NDC 68047-159-16 LoHist-D
Product NDC 68047-159
Requested package NDC 68047-159-16
11-digit product format 680470159
Labeler code 68047
Product ID 68047-159_57b0b63b-385b-72c7-e063-6394a90abd3d
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate / Pseudoephedrine HCl
Dosage form LIQUID
Route ORAL
Labeler Larken Laboratories, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-30
Substance CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 2; 30 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-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 LoHist-D
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/5mL PSEUDOEPHEDRINE HYDROCHLORIDE 30 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 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1053618 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 99 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68047-159-16 68047015916 473 mL in 1 BOTTLE (68047-159-16) 473 ml 2026-07-30 No No Current