FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pyrilamine Maleate and Dextromethorphan Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/5mL
PYRILAMINE MALEATE7.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1423307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd068449-9d24-41e6-8a6e-f69c9fe263f2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-398-16Pyrilamine Maleate and Dextromethorphan Hydrobromide473 mL in 1 BOTTLELIQUID4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-398-16ML - Milliliter69367-3986c526e72-5e66-4165-ac3f-9c5460d3c00a12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-398PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240829_dd068449-9d24-41e6-8a6e-f69c9fe263f2.zip

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 130 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINTHE KROGER CO430c6604-93a7-4df6-a657-ba438aa614252024-12-18WarningsExact identifier
application number: M012
Discount Drugmart Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart, Inc1ac281e1-22ea-42f8-98fe-ab3d5ff9a2082024-12-18WarningsExact identifier
application number: M012
TopCare Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC4c50233e-1dcb-427d-ba63-1538cf3700612024-12-18WarningsExact identifier
application number: M012
Dollar General Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINDolgencorp, LLC718f08d2-3757-4f3e-915e-3e4982ad090f2024-12-18WarningsExact identifier
application number: M012
Good Neighbor Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmerisourceBergen Drug Corpe4610d53-4459-43a0-9351-f0ac8586df602024-12-18WarningsExact identifier
application number: M012
Always Save Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEValu Merch5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f62024-12-17WarningsExact identifier
application number: M012
ChestrubCAMPHOR MENTHOL EUCALYPTUS OILDelta Brands Inc8e6f731f-c16a-41b2-9786-0cab588cfc8e2024-12-17WarningsExact identifier
application number: M012
Mentholatum Nighttime Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company5539ae74-9723-480d-b35f-0a6644bf54ad2024-12-17WarningsExact identifier
application number: M012
Mentholatum No Mess Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyf4675bc1-01cc-4a33-a3bf-bfc99230fe322024-12-17WarningsExact identifier
application number: M012
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1423307dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral SolutionPSNdd068449-9d24-41e6-8a6e-f69c9fe263f22
1423307dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral SolutionSCDdd068449-9d24-41e6-8a6e-f69c9fe263f22
1423307dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral SolutionSYdd068449-9d24-41e6-8a6e-f69c9fe263f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-398-1669367039816473 mL in 1 BOTTLE (69367-398-16) 473 ml2024-07-15NoNoCurrent