Pyrilamine Maleate and Dextromethorphan Hydrobromide

Product NDC: 69367-398
11-digit product format: 693670398
Labeler code: 69367
Product ID: 69367-398_c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrilamine Maleate and Dextromethorphan Hydrobromide
Dosage form: LIQUID
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-15
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE
Active strength: 7.5; 7.5 mg/5mL; mg/5mL
Pharmacologic classes: 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	7.5 mg/5mL
PYRILAMINE MALEATE	7.5 mg/5mL

Field, Values table
Field	Values
Unii	9D2RTI9KYH, R35D29L3ZA
Rxcui	1423307

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69367-398-16	Pyrilamine Maleate and Dextromethorphan Hydrobromide	473 mL in 1 BOTTLE	LIQUID	473		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-398	PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]	2	Current NDC, 1 package rows	20240829_dd068449-9d24-41e6-8a6e-f69c9fe263f2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
R35D29L3ZA	PYRILAMINE MALEATE	59-33-6	PYRILAMINE MALEATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1423307	dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral Solution	PSN	dd068449-9d24-41e6-8a6e-f69c9fe263f2	2
1423307	dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral Solution	SCD	dd068449-9d24-41e6-8a6e-f69c9fe263f2	2
1423307	dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral Solution	SY	dd068449-9d24-41e6-8a6e-f69c9fe263f2	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69367-398-16	69367039816	473 mL in 1 BOTTLE (69367-398-16)	473 ml	2024-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pyrilamine Maleate and Dextromethorphan Hydrobromide	Westminster Pharmaceuticals, LLC	2024-08-26	HUMAN OTC DRUG LABEL	2