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
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1861935Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ccc9e56-32a4-450f-8412-5814b6aef285Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-301-01Stona1 in 1 CARTONLOZENGE16
49873-301-01Stona12 in 1 BLISTER PACKLOZENGE126

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHSTONA TROCHE (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [SATO PHARMACEUTICAL CO., LTD.]3
dextromethorphanACTIVE MOIETY7355X3ROTSSTONA TROCHE (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [SATO PHARMACEUTICAL CO., LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-301STONA (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [SATO PHARMACEUTICAL CO., LTD.]6Current NDC, Legacy NDC, 2 package rows20231129_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 160 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Chest Congestion DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINWalgreense4515d0e-c12b-40cd-8218-6d91476cfebd2024-06-21WarningsExact identifier
application number: M012
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETARGET CORPORATION135d2212-2122-b7a1-e063-6294a90aa5f52024-06-07WarningsExact identifier
application number: M012
up and up daytime honey cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETarget Corporation29da4b94-8f8e-48e8-909f-8476e3b39d782024-06-06WarningsExact identifier
application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCITARGET Corporatione3da3003-88e3-4431-8b65-e61e177289012024-06-04WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATEFoundation Consumer Healthcare15c3570c-bd00-8e43-e063-6294a90a86832024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare176be362-5237-edd8-e063-6294a90a4aef2024-06-01WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare179115ad-d610-99b2-e063-6294a90ae7112024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CoughDIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Healthcare179259a9-231e-df03-e063-6294a90a145e2024-06-01WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CoughBROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Healthcare1820e7c7-bc11-9061-e063-6394a90ae5812024-06-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLHaleon US Holdings LLC682c5a4b-5ded-4276-903f-1ef1141ae5182024-06-01WarningsExact identifier
application number: M012
Maximum Strength Nasal DecongestantOXYMETAZOLINE SPRAYCVS Healthdf1f8bda-7bf3-4755-9169-f2a81d824cbe2024-05-31WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healtha78d29ed-019b-4014-ae6f-c60c75d19c892024-05-31WarningsExact identifier
application number: M012
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc6594c117-6ffc-4bda-8bbf-e91c810f2c3f2024-05-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI1aba9b7c-8328-4a9f-8ce2-39648b2d8ae42024-05-23WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIfdf63308-fe7b-4613-a012-ed5e4c9f8ffe2024-05-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIe61ab02d-f932-403f-a4f7-0ca3546072232024-05-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1861935dextromethorphan HBr 10 MG Oral LozengePSN1ccc9e56-32a4-450f-8412-5814b6aef2856
1861935dextromethorphan hydrobromide 10 MG Oral LozengeSCD1ccc9e56-32a4-450f-8412-5814b6aef2856
1861935dextromethorphan HBr 10 MG Oral LozengeSY1ccc9e56-32a4-450f-8412-5814b6aef2856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-301-01498730301011 BLISTER PACK in 1 CARTON (49873-301-01) / 12 LOZENGE in 1 BLISTER PACK1 blister pack1995-11-190000-00-00NoNoCurrent