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 147 of 240 · 4,790 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLC1ea15426-4f3d-4a97-a590-6bd73bc6cbcd2025-05-19WarningsExact identifier
unii: 9D2RTI9KYH
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
unii: L7T10EIP3A
MUCUS RELIEFGUAIFENESINSDA Laboratories, Inc.1fd16b06-0c3e-4a30-ae6a-7b1632189c202025-05-16WarningsExact identifier
unii: 495W7451VQ
Tussin DM Sugar freeDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.3a521b65-fb35-4cc3-b826-88513afda0f92025-05-16WarningsExact identifier
rxcui: 996520
unii: 9D2RTI9KYH
unii: 495W7451VQ
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC51c7628a-c7cf-498f-8fb1-db732e2b8b6e2025-05-16WarningsExact identifier
unii: 9D2RTI9KYH
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd352798e1-1e09-3d47-e063-6394a90ad4042025-05-15WarningsExact identifier
unii: L7T10EIP3A
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd35285d62-c660-a056-e063-6294a90aabc82025-05-15WarningsExact identifier
unii: L7T10EIP3A
Bactimicina Childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDLC Laboratories, Inc.d407a583-07ae-4d47-b15a-24b5865c82da2025-05-15WarningsExact identifier
unii: 9D2RTI9KYH
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDERB Health (US) LLC35322238-d498-1a52-e063-6394a90ac9c42025-05-15WarningsExact identifier
unii: 9D2RTI9KYH
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCa1405038-80f2-45e5-bd8c-8c6b0ee348be2025-05-15WarningsExact identifier
unii: 9D2RTI9KYH
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIb919f0fe-fae0-4bd8-9ccd-d7569b2a70702025-05-13WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Robitussin Honey Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC6afaf85b-bf0c-4c99-acf3-a34f06be20f12025-05-13WarningsExact identifier
unii: 9D2RTI9KYH
Robitussin Honey Severe Cough, Flu Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC77be57fb-0ae5-4fad-97f3-b6a4b57383a92025-05-13WarningsExact identifier
unii: 9D2RTI9KYH
cough dmDEXTROMETHORPHAN POLISTIREXATLANTIC BIOLOGICALS CORP.73aede9d-37dd-4aa5-a906-0e0c94cecff12025-05-12WarningsExact identifier
unii: 9D2RTI9KYH
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact identifier
unii: L7T10EIP3A
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
unii: L7T10EIP3A
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
unii: 9D2RTI9KYH
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
unii: L7T10EIP3A
GuaifenesinGUAIFENESINAurohealth LLC4ec1477e-6e33-4c40-a476-cf7f4f00192b2025-05-08WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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