Home NDC 82876-983 Earthmed Soothe Chewable Watermelon
Product NDC 82876-983
11-digit product format 828760983
Labeler code 82876
Product ID 82876-983_4395440d-5a64-b9c7-e063-6394a90ab4ac
Type HUMAN OTC DRUG
Nonproprietary name Citric Acid
Dosage form CHEWABLE GEL
Route ORAL
Labeler Earthmed LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-14
Substance CITRIC ACID MONOHYDRATE
Active strength 1.5 g/108.27g
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 Earthmed Soothe Chewable Watermelon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITRIC ACID MONOHYDRATE 1.5 g/108.27g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2968PHW8QP Internal UNII 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 82876-983-20 Earthmed Soothe Chewable Watermelon 108.27 g in 1 BAG CHEWABLE GEL 108.27 1
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 22 of 34 · 678 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82876-983-20 82876098320 108.27 g in 1 BAG (82876-983-20) 108.27 g 2025-11-14 No No Current