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 231 of 236 · 4,703 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	Proficient Rx LP	68a4c521-6db0-4e94-9906-96e96e251301	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9D2RTI9KYH
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR unii: XF417D3PSL
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	d139fd8d-66fd-4484-8e78-ed90c505d999	2022-02-08	Warnings	Exact identifier unii: 495W7451VQ
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Aewajin HasuoShampoo	MENTHOL, SALICYLIC ACID, PANTHENOL	MISOCOS	d4950ac9-8c05-989a-e053-2995a90ac6b7	2022-01-02	Warnings	Exact identifier unii: L7T10EIP3A
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	d763511e-f1a7-4014-94b9-f7ad8f023ff4	2021-12-02		Exact identifier unii: XF417D3PSL
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	cf9f43a0-c750-4cf0-ac49-176ab2105aab	2021-12-02		Exact identifier unii: XF417D3PSL
NOCOLD-F	ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Lydia Co., Ltd.	d0b20c56-de2a-1489-e053-2995a90a6a06	2021-11-13	Warnings	Exact identifier unii: 9D2RTI9KYH
basic care cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	8127c389-c1e3-4f2e-b306-13587b5b50c4	2021-08-09	Warnings	Exact identifier unii: 9D2RTI9KYH
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
SPORTS gel	MENTHOL	Aloe Vera Korea Co.,Ltd.	c84fc51c-0e2c-56a2-e053-2995a90a077e	2021-08-03	Warnings	Exact identifier unii: L7T10EIP3A
basic care childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Amazon.com Services LLC	dcfb71a1-2a5b-4847-a23d-bbe381badcf6	2021-07-20	Warnings	Exact identifier unii: 9D2RTI9KYH
Signature Care Cough Relief	DEXTROMETHORPHAN POLISTIREX	Safeway	f95d0519-e96b-45fe-974c-8fe6b9b8c88c	2021-07-13	Warnings	Exact identifier unii: 9D2RTI9KYH
basic care mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	ac01ad52-483a-4cce-9279-51ceecada9b9	2021-07-13	Warnings	Exact identifier unii: 9D2RTI9KYH unii: 495W7451VQ
CO COOL	MENTHOL, PEPPERMINT OIL, PINUS PUMILIO BRANCH/LEAF OIL	Lydia Co., Ltd.	90b213fe-f7b9-555c-e053-2a95a90a1df3	2021-06-27	Warnings	Exact identifier unii: L7T10EIP3A
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	Warnings	Exact identifier unii: 495W7451VQ
Mucus Relief	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	01af03f1-5d1b-4893-b7db-7092ba66e842	2021-05-03	Warnings	Exact identifier unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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