FDA.reportPublic FDA data

Stona Cough

Product NDC
49873-302
11-digit product format
498730302
Labeler code
49873
Product ID
49873-302_09fb9b1c-b0c7-95a9-e063-6394a90a51db
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SYRUP
Route
ORAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-01-03
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 200 mg/10mL; mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/10mL
GUAIFENESIN200 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234473Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b638db4-5ed3-4665-abcd-f95e677adbd8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-302-01Stona Cough120 mL in 1 BOTTLESYRUP1204
49873-302-01Stona Cough1 in 1 CARTONSYRUP14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
GUAIFENESINACTIVE MOIETY495W7451VQSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
BETADEXINACTIVE INGREDIENTJV039JZZ3ASTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8STONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SUCROSEINACTIVE INGREDIENTC151H8M554STONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RSTONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-302STONA COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231113_0b638db4-5ed3-4665-abcd-f95e677adbd8.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 79 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Sore Throat LozengeBENZOCAINEAmerican Sales49248a40-1ca3-6dd1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLAmerican Sales4896cbd1-57dd-1fc6-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLCVS Pharmacy3bdd24a8-3b44-00cd-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLCVS Pharmacy3c125b3a-e58f-5c06-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
CVS Menthol Cough DropsMENTHOLCVS Pharmacyde97d13b-bb67-d0e6-e053-2995a90aeb2c2025-12-07WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLAmerican Sales34dd34d1-1a08-3470-e054-00144ff8d46c2025-12-06WarningsExact identifier
application number: M012
DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis656ea9ba-c9cf-44c6-af40-b8ba292ce38a2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLCa79b5541-864b-412a-a085-96986ed6af592025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.346f32cb-74cb-4896-b770-76d5f829a17d2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.530b2d27-5883-489e-87fa-90b45eb93b3c2025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, AntihistamineCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ee666963-e686-4374-b52b-a677f1cd41142025-12-05WarningsExact identifier
application number: M012
Afrin No-Drip Allergy SinusOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC3beb5839-7422-449d-e054-00144ff88e882025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
application number: M012
Afrin Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.a49a506e-aca2-4af0-a50b-dca2c031e61d2025-12-05WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.a746cef4-1fb4-45cf-e053-2995a90a02c82025-12-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
application number: M012
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234473dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN0b638db4-5ed3-4665-abcd-f95e677adbd84
1234473dextromethorphan hydrobromide 3 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD0b638db4-5ed3-4665-abcd-f95e677adbd84
1234473dextromethorphan hydrobromide 15 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY0b638db4-5ed3-4665-abcd-f95e677adbd84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-302-01498730302011 BOTTLE in 1 CARTON (49873-302-01) / 120 mL in 1 BOTTLE1 bottle2001-01-030000-00-00NoNoCurrent