Home NDC 68047-120 LoHist
Product NDC 68047-120
11-digit product format 680470120
Labeler code 68047
Product ID 68047-120_56be316a-4767-3a8e-e063-6294a90a46c1
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 2003-09-15
Marketing end 2030-05-21
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
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
Brand name suffix D 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68047-120-16 LoHistD 473 mL in 1 BOTTLE LIQUID 473 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 SACCHARIN SODIUM ANHYDROUS INACTIVE INGREDIENT I4807BK602 LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68047-120 LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20241012_93c9ad4f-3376-48c2-8276-0375663acd01.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 73 of 178 · 3,551 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 68047-120-16 68047012016 473 mL in 1 BOTTLE (68047-120-16) 473 ml 2003-09-15 2030-05-21 No No Current