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
Label	Manufacturer	Effective date	Type
Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc.	Rising Pharma Holdings, Inc.	2026-09-22	HUMAN OTC DRUG LABEL

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-313-01	ML - Milliliter	57237-313	b4b7f776-ef79-4ae7-91fd-645b4e7d702c	1	2023-07-06
57237-313-18	ML - Milliliter	57237-313	1a032e32-c5d7-44b4-8e28-95a98c950ff8	1	2023-07-06

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 163 of 240 · 4,790 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier unii: L7T10EIP3A
Foster and Thrive Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a1661a66-5e8c-4144-9c82-cbbcc75fb222	2024-12-23	Warnings	Exact identifier unii: 495W7451VQ
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier unii: L7T10EIP3A
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	6299e352-116e-43f2-b40f-c704a7bd5d61	2024-12-23	Warnings	Exact identifier rxcui: 996520 unii: 9D2RTI9KYH unii: 495W7451VQ
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier unii: L7T10EIP3A
Equaline Chest Congestion Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	ad9fde8b-10cd-4778-917d-1ed6b67e5ab1	2024-12-23	Warnings	Exact identifier unii: 495W7451VQ
Equaline Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	United Natural Foods, Inc. dba UNFI	a40f5893-eb96-4e0e-b965-d78293c48dc9	2024-12-23	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Household Antigens	ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUM	Energique, Inc.	f3db63df-62a4-48d6-92e7-94e4a5701552	2024-12-20	Warnings	Exact identifier unii: 6DC9Q167V3 unii: Z8IX2SC1OH unii: A2I8C7HI9T
Tukol X-Pecto Miel Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	b9d32964-5bd7-44b0-be98-827d5310ed4f	2024-12-20	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Halls Honey Vanilla	MENTHOL	Mondelez Global LLC	8e94a1b8-8915-4595-b097-8a0a319d54aa	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Halls Sugar Free Mentho-Lyptus	MENTHOL	Mondelez Global LLC	96046858-c57b-426e-8279-91b35e05bcdb	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Tukol Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	aef2ad43-145d-4abc-bccc-2c5fdd6882f9	2024-12-20	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Childrens Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores, Inc.	50a0eaa5-fa73-4d84-86fc-3546c85cf353	2024-12-20	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Childrens Tussnex	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	19e9678d-ac34-4af8-a80f-d08fce0a5f0e	2024-12-19	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Vaporising Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	New Pride Corp	f66476d5-036b-0b1c-e053-2a95a90a0a07	2024-12-19	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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