FDA.reportPublic FDA data

NDC 57237-312-05 - 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
57237-312
Requested NDC
57237-312-05
Package NDCs from labels
57237-312-05, 57237-312-51
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
57237-312-05Dextromethorphan HBr. and Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION55
57237-312-51Dextromethorphan HBr. and Guaifenesin100 in 1 BOX, UNIT-DOSESOLUTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-312DEXTROMETHORPHAN 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
57237-312-05ML - Milliliter57237-312b4445953-07cc-4aef-bec3-b0d9427f679812023-07-06
57237-312-51ML - Milliliter57237-312474f4a31-90f7-44ca-8151-f945ba6b798712023-07-06

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 121 of 240 · 4,800 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Winco Cold and Hot Medicated Patch LargeMENTHOLWINCO FOODS, LLCaf0d86c4-f74e-2dbe-e053-2a95a90a74c12025-10-22WarningsExact identifier
unii: L7T10EIP3A
Coralite Cold and HotMENTHOLUnited Exchange Corp.064a6149-a0e2-8a73-e063-6394a90a79532025-10-22WarningsExact identifier
unii: L7T10EIP3A
Topical AnalgesicMENTHOLYoungevity International Inc.b4693947-f5b3-6fd3-e053-2995a90ab5812025-10-22WarningsExact identifier
unii: L7T10EIP3A
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
unii: L7T10EIP3A
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Coralite Extra Strength Pain Relief Sleeve WristMENTHOLUnited Exchange Corp.ae314478-b8ab-4e90-bd0a-7a882d5c1b2e2025-10-21WarningsExact identifier
unii: L7T10EIP3A
Coralite Cold and HotMENTHOLUnited Exchange Corp.85bd7658-e951-7daf-e053-2a91aa0a9f542025-10-21WarningsExact identifier
unii: L7T10EIP3A
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact identifier
unii: L7T10EIP3A
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
unii: L7T10EIP3A
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsExact identifier
rxcui: 996520
unii: 9D2RTI9KYH
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsExact identifier
rxcui: 996520
unii: 9D2RTI9KYH
unii: 495W7451VQ
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC1539c3d4-d982-7d4e-e063-6394a90ad7d62025-10-21WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
unii: 495W7451VQ
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
unii: L7T10EIP3A
NUEDEXTADEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEAvanir Pharmaceuticals, Inc.484e0918-3442-49dc-8ccf-177f1f3ee9f32025-10-21Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI311e2b6b-21cb-4b4c-a78d-a0732d29602f2025-10-21WarningsExact identifier
unii: 9D2RTI9KYH
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
unii: L7T10EIP3A
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
unii: L7T10EIP3A
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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