Stona Cough

Product NDC
49873-302
Requested package NDC
49873-302-01
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

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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu plus Congestion NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALMART INC.1236b463-0073-44b5-a516-5b7c06a408872026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact 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