NDC 57237-312-05 - 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: 57237-312
Requested NDC: 57237-312-05
Package NDCs from labels: 57237-312-05, 57237-312-51
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
57237-312-05	Dextromethorphan HBr. and Guaifenesin	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		5
57237-312-51	Dextromethorphan HBr. and Guaifenesin	100 in 1 BOX, UNIT-DOSE	SOLUTION	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-312	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
57237-312-05	ML - Milliliter	57237-312	b4445953-07cc-4aef-bec3-b0d9427f6798	1	2023-07-06
57237-312-51	ML - Milliliter	57237-312	474f4a31-90f7-44ca-8151-f945ba6b7987	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 1 of 243 · 4,855 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	1022767d-a456-4fbc-95cf-91337c74c330	2026-10-01	Warnings	Exact identifier unii: 495W7451VQ
COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	FORTUNE PHARMACAL COMPANY LIMITED	33e1bec0-323b-40b7-809a-cb65a71ad0ce	2026-09-17	Warnings	Exact identifier unii: 9D2RTI9KYH
12 hr relief cough dm	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	03c44e2f-d6e3-4c78-9c9a-92d1708a62fe	2026-09-16	Warnings	Exact identifier unii: 9D2RTI9KYH
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	9a9c5c6b-94fe-484a-a879-12c29cbdefe4	2026-09-11	Warnings	Exact identifier unii: L7T10EIP3A
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier unii: 9D2RTI9KYH
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Foster and Thrive Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	f4ab5611-8abb-4c1f-8f85-917e2e1328e3	2026-09-09	Warnings	Exact identifier unii: 495W7451VQ
OTTFFSS SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5b0991b6-59cc-59b3-e063-6394a90a7693	2026-09-09	Warnings	Exact identifier unii: L7T10EIP3A
THITFAM SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a78d096-4740-8dd4-e063-6294a90a651f	2026-09-09	Warnings	Exact identifier unii: L7T10EIP3A
Magic Cream	PAIN RELIEVING OINTMENT	Jiangxi Baikang Medical Products Co., Ltd.	5b0f2515-47e9-603f-e063-6294a90af9d4	2026-09-09	Warnings	Exact identifier unii: L7T10EIP3A
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH
Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	cd7955b2-8eee-43d3-973f-6de2f3929512	2026-09-09	Warnings	Exact identifier unii: 495W7451VQ
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Maximum Strength Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	5a6f88b8-3436-3321-e063-6294a90a3a2e	2026-09-09	Warnings	Exact identifier unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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