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 217 of 236 · 4,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
unii: 9D2RTI9KYH
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
unii: 9D2RTI9KYH
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMSheffield Pharmaceuticals LLC60d1d826-a53e-42e5-bc30-1b2c2690445b2023-11-28WarningsExact identifier
unii: L7T10EIP3A
Thera Plus Cold Therapy Pain Relieving MentholMENTHOLFourstar Group USA, Inc.0a462c91-5300-e282-e063-6394a90a4cc22023-11-27WarningsExact identifier
unii: L7T10EIP3A
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC251a133e-73ac-4d0e-bce7-30dcfc6b0de62023-11-22WarningsExact identifier
unii: L7T10EIP3A
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
unii: 9D2RTI9KYH
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRA-S Medication Solutions786607e9-ee2d-4510-8556-857032e4053f2023-11-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
UtaSprayMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCc641ab11-cd00-4e23-ace7-8178739084f02023-11-21WarningsExact identifier
unii: L7T10EIP3A
Top Medicated OilCAMPHOR, MENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCb2f0d1e1-7d03-434e-be39-9f980459690c2023-11-21WarningsExact identifier
unii: L7T10EIP3A
BT Pain Relief BalmMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLC50112419-c934-4d3a-9ea6-9b089f516a6d2023-11-21WarningsExact identifier
unii: L7T10EIP3A
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC91324910-27cf-424f-9e9b-6173f2d7acbf2023-11-21WarningsExact identifier
unii: L7T10EIP3A
Zhong Hua Feng Shi Die Da Gao External Analgesic PlasterMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCceaa383d-8df0-1438-e053-2a95a90a2b6b2023-11-20WarningsExact identifier
unii: L7T10EIP3A
Dit Da ShuiMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLC5d45cb48-3e88-4d58-81d2-6f88d7a821342023-11-20WarningsExact identifier
unii: L7T10EIP3A
Herbal BalmMETHYL SALICYLATE, MENTHOL ANDBig 5 Nutrition LLC09b3b86d-3434-428b-b0a8-e8dfd7c0b52a2023-11-20WarningsExact identifier
unii: L7T10EIP3A
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
unii: 9D2RTI9KYH
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
unii: L7T10EIP3A
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
unii: L7T10EIP3A
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
unii: L7T10EIP3A
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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