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 230 of 236 · 4,703 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sterile Water WATER Fresenius Kabi USA, LLC f42ac50f-0ec5-4713-a4c8-99d972d90bed 2022-06-22 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R GUAIFENESIN GUAIFENESIN PAI Holdings, LLC dba PAI Pharma c2e53fb5-2798-47c8-9285-d1077d46e629 2022-06-14 Warnings Exact identifier unii: 495W7451VQ Sterile Water WATER Fresenius Kabi USA, LLC e71c6c83-d518-496c-b2ab-efd5987e4783 2022-06-09 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Guaifenesin D GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE CVS Pharmacy, Inc. 4dee850b-b170-4ef9-ae02-3db9bfa05abe 2022-06-08 Warnings Exact identifier unii: 495W7451VQ Mucus Relief DM MUCUS RELIEF DM TopCo Associates, LLC 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 2022-06-07 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ signature care childrens 12 hour cough relief DEXTROMETHORPHAN POLISTIREX Safeway 62d71572-d157-484a-8676-7ce6da413ee8 2022-06-01 Warnings Exact identifier unii: 9D2RTI9KYH GUAIFENESIN AND DEXTROMETHORPHAN HBR GUAIFENESIN AND DEXTROMETHORPHAN HBR Kroger Company 11b3c01a-93c5-4cd1-8422-d3c3d19d8dff 2022-05-24 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ GUAIFENESIN AND DEXTROMETHORPHAN HBR GUAIFENESIN AND DEXTROMETHORPHAN HBR Kroger Company 8f7200ff-3e4d-414a-a1f9-fe8daac67cb1 2022-05-24 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ Mucus Relief DM Immediate Release MUCUS RELIEF DM Good Sense 26a199bf-57e5-4f36-b40c-83a1187e4870 2022-05-18 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ Mucus Relief DM Immediate Release MUCUS RELIEF DM Allegiant Health 731f8608-ad5b-491e-a4d4-2bb0c423fed5 2022-05-18 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ Mucus Relief GUAIFENESIN WinCo Foods, LLC 90e72075-d08a-41c8-a6b0-5fbb99a7ea41 2022-05-11 Warnings Exact identifier unii: 495W7451VQ GUAIFENESIN GUAIFENESIN Walmart Stores, Inc. 794e383d-2cae-49d7-9c2d-ae5547bde536 2022-05-09 Warnings Exact identifier unii: 495W7451VQ GUAIFENESIN GUAIFENESIN Kroger Company d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d 2022-04-29 Warnings Exact identifier unii: 495W7451VQ ACD Blood-Pack Units (PL 146 PLASTIC) ANTICOAGULANT CITRATE DEXTROSE (ACD) Fenwal, Inc. ba894daa-688e-4a9e-bd74-e71797f951bb 2022-04-27 Exact identifier unii: XF417D3PSL Guaifenesin Extended Release GUAIFENESIN Kroger Company d434656a-221b-40fc-81ad-2b698be1aa33 2022-04-20 Warnings Exact identifier unii: 495W7451VQ berkley and jensen mucus relief GUAIFENESIN BJWC 433588eb-18ad-473f-9527-4947a143824e 2022-04-19 Warnings Exact identifier unii: 495W7451VQ basic care mucus er max GUAIFENESIN Amazon.com Services LLC 9ab3d192-0fd4-48fd-95ea-3182c63a7327 2022-04-12 Warnings Exact identifier unii: 495W7451VQ basic care mucus er GUAIFENESIN Amazon.com Services LLC 14213a15-5842-456f-a5ab-654268c58f78 2022-04-11 Warnings Exact identifier unii: 495W7451VQ Guaifenesin and Pseudoephedrine Hydrochloride GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE PUBLIX SUPER MARKETS, INC c857bcd9-6696-40d5-93c0-65097598cd4b 2022-04-08 Warnings Exact identifier unii: 495W7451VQ Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE Proficient Rx LP 1b79a7d8-a8f4-4525-8b94-3e317fc5a717 2022-04-01 Warnings, Adverse reactions Exact identifier unii: 9D2RTI9KYH
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.