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 165 of 240 · 4,790 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Tussnex Multi-symptom cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	9028676e-d725-4afe-aa14-72235825aa17	2024-12-19	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Tussnex FM Cold and Sinus	ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	04c6bb6a-d2f8-4322-afba-e240e8090176	2024-12-19	Warnings	Exact identifier unii: 495W7451VQ
Tussnex FM Severe cough and congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	387df403-7803-4031-915e-8de9b103a162	2024-12-19	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Maximum strength Tussnex FM DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Guardian Drug Company	0bae53e3-9661-4bc6-9fcc-da7fa131b034	2024-12-19	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Refenesen Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Reese Pharmaceutical Co	6046dc50-f162-4e2d-aa3c-7d27efad477d	2024-12-18	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
Sunmark Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	2024-12-18	Warnings	Exact identifier unii: 495W7451VQ
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	1c33a01f-1186-4a19-b639-a9cd49245220	2024-12-18	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
HealthMart Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c	2024-12-18	Warnings	Exact identifier unii: 495W7451VQ
DG Health Immediate Release Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	f60a9d1b-7a63-43d3-b843-e1f31cf78873	2024-12-18	Warnings	Exact identifier unii: 495W7451VQ
Maximum Strength Medicated Foot Powder	MEDICATED FOOT POWDER	Jell Pharmaceuticals Pvt. Ltd.	cdaae985-5363-e9d2-e053-2995a90a2682	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80cad8d-da4c-049d-e053-2a95a90ac20e	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Orazen Inc	ecddaa3b-e18f-1c74-e053-2995a90ad86a	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Rite Aid Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Rite Aid	dfedbef1-8062-432d-e053-2a95a90a09e9	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
TheraCare Pain Relief Medicated	LIDOCAINE AND MENTHOL	Veridian Healthcare	0d092461-85fe-acf6-e063-6294a90a5aae	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Pain Relieving Patches	CAMPHOR MENTHOL METHYL SALICYTATE	Walgreen Company	13486792-d3d1-4585-beb7-24720b9edaae	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Large Pain Relieving	CAMPHOR MENTHOL METHYL SALICYTATE	Walgreen Company	f9ecfff2-3367-415f-bf68-1a8b7dfe84b8	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Extra Large Cool and Heat Patch	MENTHOL	Walgreen Company	9fd83f89-0dd0-4f22-9c8e-a353864ea43b	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Extra Strength Cold and Hot Menthol Patch	MENTHOL	Rite Aid Corporation	bd46ac50-aaf8-b4e8-e053-2995a90aea61	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Rite Aid Hot and Cold Back Patch	MENTHOL	Rite Aid Corporation	efa51d1f-ed09-680c-e053-2a95a90af1b2	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A
Hot and Cold Medicated Patch	MENTHOL	Veridian Healthcare	67446b19-3296-42f1-9e5f-2bb7938017c0	2024-12-18	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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