Home NDC 68047-120 LoHist
Product NDC 68047-120
11-digit product format 680470120
Labeler code 68047
Product ID 68047-120_413948dd-d2dc-dac0-e063-6394a90a4db9
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
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LoHist D CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL Larken Laboratories, Inc. 93c9ad4f-3376-48c2-8276-0375663acd01 2026-07-16 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.
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 Identifiers# Field, Values table Field Values Unii V1Q0O9OJ9Z, 6V9V2RYJ8N Rxcui 1053618
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
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 0000-00-00 No No Current