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 234 of 236 · 4,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Mucus ReliefGUAIFENESIN 200 MGAphena Pharma Solutions - Tennessee, LLC2ae3c1e1-2a12-444d-a763-590320d373e12018-07-18WarningsExact identifier
unii: 495W7451VQ
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
unii: L7T10EIP3A
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
unii: L7T10EIP3A
Avedana Cool Hot IceMENTHOLUnipack, Inc.619c8e3f-0cad-4eb1-8dbb-632f3db74ba32018-05-01WarningsExact identifier
unii: L7T10EIP3A
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Pure-AidLIDOCAINE, MENTHOLKareway Product, Inc.6679cada-f083-26e8-e053-2a91aa0adcc52018-03-02WarningsExact identifier
unii: L7T10EIP3A
Guaifenesin Extended-Release 600 mgGUAIFENESINGuardian Drug Company20f9e083-419d-429d-a570-24b312ed5d2a2018-02-28WarningsExact identifier
unii: 495W7451VQ
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tukol ADEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.651f0d7c-c76b-434d-95fd-427609b40b462017-12-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: L7T10EIP3A
MucinexGUAIFENESINAphena Pharma Solutions - Tennessee, LLC1c84bf00-ebaa-4e69-a2c6-716631d209d92017-12-18WarningsExact identifier
unii: 495W7451VQ
ICY FREEZEMENTHOLNATURAL ESSENTIALS, INC.41b2e9a0-818d-4188-8c9d-8ff7c0d0519b2017-12-01WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cherry Cough DropsMENTHOLArmy & Air Force Exchange Service5d7f7e45-7d69-10dc-e053-2991aa0a389c2017-11-08WarningsExact identifier
unii: L7T10EIP3A
Lidocaine Pain Relief PatchLIDOCAINE AND MENTHOL, UNSPECIFIED FORMFoshan Aqua Gel Biotech Co.,Ltd.3fe1a160-6508-62ea-e054-00144ff8d46c2017-11-06WarningsExact identifier
unii: L7T10EIP3A
Ultimate Topical Pain Relief PatchCAPSAICIN AND MENTHOL, UNSPECIFIED FORMFoshan Aqua Gel Biotech Co.,Ltd.33c9f8ba-903e-249e-e054-00144ff8d46c2017-11-06WarningsExact identifier
unii: L7T10EIP3A
Mucus ReliefGUAIFENESIN 400 MGRichmond Pharmaceuticals, Inc.26924bee-32cc-4499-beb0-2650ff8eb1da2017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRRichmond Pharmaceuticals, Inc59b00858-e5c9-420a-bc7e-46953722cde62017-10-30WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAdvance Pharmaceutical Inc.e507a84a-59d5-47f2-a2df-f342e4b093b42017-10-30WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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