Dextromethorphan HBr. and Guaifenesin

Product NDC: 57237-312
11-digit product format: 572370312
Labeler code: 57237
Product ID: 57237-312_914d13bb-fbd6-420f-ad2c-1df3828d18c3
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr. and Guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: M012.85
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-06-12
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 10; 100 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	100 mg/5mL

Field, Values table
Field	Values
Unii	9D2RTI9KYH, 495W7451VQ
Rxcui	996520

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

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

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	e463e60f-d0db-4ee7-9713-ddf25aa38a43	5
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	e463e60f-d0db-4ee7-9713-ddf25aa38a43	5
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	e463e60f-d0db-4ee7-9713-ddf25aa38a43	5
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	e463e60f-d0db-4ee7-9713-ddf25aa38a43	5
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	e463e60f-d0db-4ee7-9713-ddf25aa38a43	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57237-312-05	57237031205	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
57237-312-51	57237031251	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05)		2023-06-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc.	Rising Pharma Holdings, Inc.	2025-07-01	HUMAN OTC DRUG LABEL	5