Home NDC 49873-108 Stona for Children
Product NDC 49873-108
11-digit product format 498730108
Labeler code 49873
Product ID 49873-108_57efcfb1-045c-d6c7-e063-6394a90a843b
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 2027-12-31
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 for Children
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/15mL CHLORPHENIRAMINE MALEATE 2 mg/15mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 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 1236070 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 49873-108-01 Stona for Children 1 in 1 CARTON SYRUP 1 6 49873-108-01 Stona for Children 120 mL in 1 BOTTLE SYRUP 120 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded acetaminophen ACTIVE INGREDIENT 362O9ITL9D STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 chlorpheniramine maleate ACTIVE INGREDIENT V1Q0O9OJ9Z STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 acetaminophen ACTIVE MOIETY 362O9ITL9D STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 chlorpheniramine ACTIVE MOIETY 3U6IO1965U STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 dextromethorphan ACTIVE MOIETY 7355X3ROTS STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 POLYETHYLENE GLYCOL 1500 INACTIVE INGREDIENT 1212Z7S33A STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49873-108 STONA FOR CHILDREN (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SATO PHARMACEUTICAL CO., LTD.] 6 Current NDC, Legacy NDC, 2 package rows 20250120_18f3d694-9dff-407e-a264-916dbd201f9a.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 71 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 Warnings Exact identifier application number: M012
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 49873-108-01 49873010801 1 BOTTLE in 1 CARTON (49873-108-01) / 120 mL in 1 BOTTLE 1 bottle 2001-01-03 0000-00-00 No No Current