FDA.reportPublic FDA data

NDC 57237-313-01 - Dextromethorphan HBr. and Guaifenesin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57237-313
Requested NDC
57237-313-01
Package NDCs from labels
57237-313-01, 57237-313-18
Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2026-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc.Rising Pharma Holdings, Inc.2026-09-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-313-01Dextromethorphan HBr. and Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION105
57237-313-18Dextromethorphan HBr. and Guaifenesin80 in 1 BOX, UNIT-DOSESOLUTION805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-313DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [RISING PHARMA HOLDINGS, INC.]4Current NDC, 2 package rows20241013_e463e60f-d0db-4ee7-9713-ddf25aa38a43.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-313-01ML - Milliliter57237-313b4b7f776-ef79-4ae7-91fd-645b4e7d702c12023-07-06
57237-313-18ML - Milliliter57237-3131a032e32-c5d7-44b4-8e28-95a98c950ff812023-07-06

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 56 of 243 · 4,855 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.e4844ad3-6073-4c2c-9029-5c4f4ea024e82026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.0407d06e-a8d4-4522-8213-3a7a0c5e336e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.a8daefba-b985-4ef9-b900-e5647324662e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METYL SALICYLATE, THYMOLWalmart Inc.404dfa0f-8ac1-463a-9e10-fc87f70697952026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.d2515c9c-79b4-4874-be6e-fe8312477fc82026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.4da4ecf6-038e-4a64-83f7-c29d70e831742026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
unii: L7T10EIP3A
CVS PHARMACY Nighttime MS Flu ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY23cafaa1-34fe-4cef-960b-5f664ea32cb42026-02-27WarningsExact identifier
unii: 9D2RTI9KYH
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
unii: L7T10EIP3A
mucus dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc8026a56-4249-48de-b763-2d1c557317332026-02-26WarningsExact identifier
unii: 495W7451VQ
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESportpharm LLC8f4af6dd-6df4-49a7-98cf-6551369237342026-02-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tussin DM Cough and ChestDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC402969c9-945c-44b7-b018-b62f427ce5712026-02-26WarningsExact identifier
rxcui: 996520
unii: 9D2RTI9KYH
unii: 495W7451VQ
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Multi-Symptom Cold and Fever ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY2a569e47-3f17-4fc7-83d6-a3dddfd4987e2026-02-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.