Home NDC 49873-301 Stona
Product NDC 49873-301
11-digit product format 498730301
Labeler code 49873
Product ID 49873-301_0b3fbae8-f6b3-d405-e063-6394a90adecd
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide
Dosage form LOZENGE
Route ORAL
Labeler Sato Pharmaceutical Co., Ltd.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1995-11-19
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 10 mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Stona
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1861935 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 49873-301-01 Stona 1 in 1 CARTON LOZENGE 1 6 49873-301-01 Stona 12 in 1 BLISTER PACK LOZENGE 12 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49873-301 STONA (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [SATO PHARMACEUTICAL CO., LTD.] 6 Current NDC, Legacy NDC, 2 package rows 20231129_1ccc9e56-32a4-450f-8412-5814b6aef285.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 97 of 178 · 3,551 matching rows.
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 49873-301-01 49873030101 1 BLISTER PACK in 1 CARTON (49873-301-01) / 12 LOZENGE in 1 BLISTER PACK 1 blister pack 1995-11-19 0000-00-00 No No Current