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 236 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	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	54e45d89-e8c3-6fc3-e063-6394a90aac4e	2015-06-15	Warnings	Exact identifier unii: L7T10EIP3A
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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