Home NDC 57237-313-01 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57237-313-01 Dextromethorphan HBr. and Guaifenesin 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 5 57237-313-18 Dextromethorphan HBr. and Guaifenesin 80 in 1 BOX, UNIT-DOSE SOLUTION 80 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-313 DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [RISING PHARMA HOLDINGS, INC.] 4 Current NDC, 2 package rows 20241013_e463e60f-d0db-4ee7-9713-ddf25aa38a43.zip
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 222 of 236 · 4,703 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier unii: L7T10EIP3A AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 Warnings Exact identifier unii: L7T10EIP3A IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier unii: L7T10EIP3A URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier unii: L7T10EIP3A Cough Drops MENTHOL Topco Associates LLC eff68377-2273-6c6c-e053-2995a90a36b2 2023-11-03 Warnings Exact identifier unii: L7T10EIP3A Sugar Free Cough Drops MENTHOL Topco Associates LLC 096bbcaa-fce1-0fc2-e063-6294a90ad597 2023-11-03 Warnings Exact identifier unii: L7T10EIP3A TopCare Nite Time SEVERE Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE Topco Associates LLC adc8edf5-ebbe-4d94-9018-aa0dbe118112 2023-11-03 Warnings Exact identifier unii: 9D2RTI9KYH MUCOSA GUAIFENESIN TIME CAP LABORATORIES,INC d34ef2e8-adc2-48e5-a572-e354937daec6 2023-11-02 Warnings Exact identifier unii: 495W7451VQ COOL BREEZE Pain Relief MENTHOL COOL BREEZE US LLC 14dcf4ee-6778-49d4-8601-9205737432ea 2023-11-01 Warnings Exact identifier unii: L7T10EIP3A Multi-Symptom Mapap Cold Formula ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Proficient Rx LP 9bf81b26-38b4-486c-ae89-222119ce1a4f 2023-11-01 Warnings Exact identifier unii: 9D2RTI9KYH Guaifenesin Syrup and Dextromethorphan GUAIFENESIN SYRUP AND DEXTROMETHORPHAN Natco Pharma USA LLC ad9026f4-f0b6-4d02-aa44-f0460eeefc0e 2023-11-01 Warnings Exact identifier rxcui: 996520 unii: 9D2RTI9KYH unii: 495W7451VQ Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Proficient Rx LP 1ebb45e5-4541-4c95-abe1-661ef763a610 2023-11-01 Warnings Exact identifier unii: L7T10EIP3A Walgreens Cool n heat LIDOCAINE 4% MENTHOL 1% Walgreens ce168ab7-ec4a-daea-e053-2995a90af829 2023-10-31 Warnings Exact identifier unii: L7T10EIP3A Daytime Cold and Flu Relief DAYTIME COLD AND FLU RELIEF TopCo Associates, LLC d592fbb8-d4bf-444e-982e-edf6fe97dce4 2023-10-31 Warnings Exact identifier unii: 9D2RTI9KYH Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TopCo Associates, LLC 407dc4ae-882d-4a49-8884-ef048bb404cf 2023-10-31 Warnings Exact identifier unii: 9D2RTI9KYH Biofreeze Roll-On MENTHOL A-S Medication Solutions 814b37ea-5441-4cec-8794-71ca01d849ae 2023-10-30 Warnings Exact identifier unii: L7T10EIP3A OsmoFlex MENTHOL Sarati International, Inc. 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e 2023-10-27 Warnings Exact identifier unii: L7T10EIP3A Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Magno-Humphries, Inc. 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f 2023-10-27 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ Mucosa Guifenesin GUAIFENESIN Magno-Humphries, Inc. 9d22c208-d0ae-8b6a-e053-2995a90ab90a 2023-10-27 Warnings Exact identifier unii: 495W7451VQ DG Health Cough Drops Cherry Flavor MENTHOL Dollar General Corporation c7a603d8-72fb-9626-e053-2995a90a09ea 2023-10-26 Warnings Exact identifier unii: L7T10EIP3A
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.