Home NDC 54473-411 Calmicid AC
Product NDC 54473-411
11-digit product format 544730411
Labeler code 54473
Product ID 54473-411_369ae213-cd24-57ba-e063-6394a90a87a6
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, COATED
Route ORAL
Labeler Melaleuca, Inc.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-01-20
Substance FAMOTIDINE
Active strength 20 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
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 Calmicid AC
Brand name suffix Acid Reducer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QZO15J2Z8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310273 Internal RxNorm lookup 1091399 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 54473-411-01 Calmicid ACAcid Reducer 1 in 1 BOX TABLET, COATED 1 1 54473-411-50 Calmicid ACAcid Reducer 50 in 1 BOTTLE TABLET, COATED 50 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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54473-411-01 54473041101 1 BOTTLE in 1 BOX (54473-411-01) / 50 TABLET, COATED in 1 BOTTLE (54473-411-50) 1 bottle 2018-01-20 No No Current 54473-411-50 54473041150 50 in 1 BOTTLE Historical