Stona for Children

Product NDC
49873-108
11-digit product format
498730108
Labeler code
49873
Product ID
49873-108_2c0cf25a-e935-b452-e063-6394a90a6418
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-01-03
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 2; 10 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 for Children
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
CHLORPHENIRAMINE MALEATE2 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH
Rxcui1236070

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-108-01Stona for Children1 in 1 CARTONSYRUP16
49873-108-01Stona for Children120 mL in 1 BOTTLESYRUP1206

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acetaminophenACTIVE INGREDIENT362O9ITL9DSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9ZSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
acetaminophenACTIVE MOIETY362O9ITL9DSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
chlorpheniramineACTIVE MOIETY3U6IO1965USTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
dextromethorphanACTIVE MOIETY7355X3ROTSSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ASTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
SUCROSEINACTIVE INGREDIENTC151H8M554STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RSTONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-108STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.]6Current NDC, Legacy NDC, 2 package rows20250120_18f3d694-9dff-407e-a264-916dbd201f9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236070acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 15 mL Oral SolutionPSN18f3d694-9dff-407e-a264-916dbd201f9a6
1236070acetaminophen 21.7 MG/ML / chlorpheniramine maleate 0.13 MG/ML / dextromethorphan hydrobromide 0.67 MG/ML Oral SolutionSCD18f3d694-9dff-407e-a264-916dbd201f9a6
1236070APAP 21.7 MG/ML / Chlorpheniramine Maleate 0.13 MG/ML / Dextromethorphan Hydrobromide 0.67 MG/ML Oral SolutionSY18f3d694-9dff-407e-a264-916dbd201f9a6
1236070APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 15 ML Oral SolutionSY18f3d694-9dff-407e-a264-916dbd201f9a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-108-01498730108011 BOTTLE in 1 CARTON (49873-108-01) / 120 mL in 1 BOTTLE1 bottle2001-01-030000-00-00NoNoCurrent