Home NDC 68047-185-16 NoHist LQ
Product NDC 68047-185
Requested package NDC 68047-185-16
11-digit product format 680470185
Labeler code 68047
Product ID 68047-185_ee15631c-8446-0618-e053-2995a90a2168
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate and Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Larken Laboratories, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-01-06
Marketing end 0000-00-00
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 4 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68047-185 68047-185-16 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 SACCHARIN CALCIUM INACTIVE INGREDIENT 5101OP7P2I NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68047-185 NOHIST LQ (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 11 Legacy NDC 20241013_c3369d67-b945-4100-9248-178ab4f3a44a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68047-185-16 68047018516 473 mL in 1 BOTTLE (68047-185-16) 473 ml 2011-01-06 0000-00-00 No No Current