Home NDC 82673-191 Nighttime Cold and Cough
Product NDC 82673-191
11-digit product format 826730191
Labeler code 82673
Product ID 82673-191_dc74d4ef-7829-48a9-ae25-76fb92f1141c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form LIQUID
Route ORAL
Labeler KinderFarms, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-30
Marketing end 2027-12-28
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 Nighttime Cold and Cough Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82673-191-04 Nighttime Cold and Cough 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 5 82673-191-04 Nighttime Cold and Cough 1 in 1 BOX LIQUID 1 5 82673-191-04 Daytime Cough Congestion Nighttime Cold Cough 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 mL 12.5 mg in 5mL 3 82673-191-04 Daytime Cough Congestion Nighttime Cold Cough 1 in 1 BOX LIQUID 12.5 mg in 5mL 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82673-191 NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL) LIQUID [KINDERFARMS, LLC] 5 Current NDC, 2 package rows 20241003_bfcedca7-f758-4654-822a-5c431906f34d.zip 82673-191 DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC] 3 Current NDC 20240913_f2113abf-c1a3-42a6-a25e-e30a31fcad95.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 Marketing start Marketing end Sample Exclude flag Status 82673-191-04 82673019104 1 BOTTLE, PLASTIC in 1 BOX (82673-191-04) / 118 mL in 1 BOTTLE, PLASTIC 2024-05-30 2027-12-28 No No Historical