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 223 of 236 · 4,703 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freegells Cough Drops Menthol Cherry MENTHOL Riclan S.A. 8e471265-3594-451a-8921-f0db474abe85 2023-10-26 Warnings Exact identifier unii: L7T10EIP3A Freegells Cough Drops Menthol Eucalyptus MENTHOL Riclan S.A. 1141593a-f3ba-4adf-b332-f9fcb0b5a013 2023-10-26 Warnings Exact identifier unii: L7T10EIP3A Freegells Cough Drops Menthol Honey Lemon MENTHOL Riclan S.A. f6271e85-9ca2-41d3-9bff-a13670ac5b80 2023-10-26 Warnings Exact identifier unii: L7T10EIP3A Freegells Cough Drops Menthol Strawberry MENTHOL Riclan S.A. da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 2023-10-26 Warnings Exact identifier unii: L7T10EIP3A Stopain Clinical MENTHOL, UNSPECIFIED FORM Troy Manufacturing, Inc. b41091b4-0dc0-4a88-8ff6-11979b3d307a 2023-10-25 Warnings Exact identifier unii: L7T10EIP3A Stopain Clinical MENTHOL Troy Manufacturing, Inc. c8d4ae28-efc4-6a00-e053-2a95a90a40bf 2023-10-25 Warnings Exact identifier unii: L7T10EIP3A Cryo10 Topical Analgesic MENTHOL Element 26 LLC ff1d2140-9302-918c-e053-6394a90acb9a 2023-10-25 Warnings Exact identifier unii: L7T10EIP3A Stopain Clinical MENTHOL Troy Manufacturing, Inc. 3336cc35-e773-4705-84b5-61040604beef 2023-10-25 Warnings Exact identifier unii: L7T10EIP3A XtraCare Ice Cold Topical Analgesic Gel MENTHOL Rejoice International d38f3099-d940-44d8-aa7f-404157c5e0e3 2023-10-24 Warnings Exact identifier unii: L7T10EIP3A TheraPlus Plus MENTHOL Zhejiang Jingwei Pharmaceutical Co., Ltd. d4119f84-eb60-4134-b58e-de13d9601199 2023-10-24 Warnings Exact identifier unii: L7T10EIP3A ALKA SELTZER PLUS Cold Day and Night Effervescent ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE Sincronia Logistica, S.A. de C.V. c478df69-823a-4112-8f44-323249a9f38f 2023-10-23 Warnings Exact identifier unii: 9D2RTI9KYH MUCINEX GUAIFENESIN A-S Medication Solutions 08ea92cc-4a0f-44c9-9edf-71f67e014431 2023-10-23 Warnings Exact identifier unii: 495W7451VQ ROBAFEN DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN A-S Medication Solutions d5965f49-2b89-425c-9909-c75c87f930fc 2023-10-22 Warnings Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ Night-Time Cold and Flu Relief ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR HealthLife of USA 2ffd62a6-703f-4cb0-bb13-49719c004d00 2023-10-21 Warnings Exact identifier unii: 9D2RTI9KYH Day-Time Cold and Flu Relief ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HealthLife of USA c5f6cf22-2aaa-40e1-b7b3-448e55898d62 2023-10-21 Warnings Exact identifier unii: 9D2RTI9KYH PENTREXCILINA ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE Healthlife of USA ae9ada14-0ec8-4c01-a874-237f2108936a 2023-10-21 Warnings Exact identifier unii: 9D2RTI9KYH Guaifenesin GUAIFENESIN APNAR PHARMA LP e5004c10-3877-c199-e053-2a95a90aa8ac 2023-10-21 Boxed warning, Warnings Exact identifier unii: 495W7451VQ NUMOTIZINE MENTHOL Hobart Laboratories, Inc. 9a29ad1b-4ba3-403f-90c9-ee7582fe4535 2023-10-20 Warnings Exact identifier unii: L7T10EIP3A ZYLOTROL MAXIMUM PAIN LIDOCAINE 4%, MENTHOL 1% Asclemed USA, Inc. 0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd 2023-10-20 Warnings Exact identifier unii: L7T10EIP3A Zylotrol LIDOCAINE HCL 4%, MENTHOL 1% Asclemed USA, Inc. e13984ea-73a9-2894-e053-2995a90a8ed6 2023-10-16 Warnings Exact identifier unii: L7T10EIP3A
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.