FDA.reportPublic FDA data

POLY-HIST DM

Product NDC
50991-271
11-digit product format
509910271
Labeler code
50991
Product ID
50991-271_5025c99f-b947-e2e0-e063-6394a90a13fb
Type
HUMAN OTC DRUG
Nonproprietary name
DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR
Dosage form
LIQUID
Route
ORAL
Labeler
POLY PHARMACEUTICALS, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DEXCHLORPHENIRAMINE MALEATE
Active strength
10; 1 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
2027-12-31
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
POLY-HIST DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
DEXCHLORPHENIRAMINE MALEATE1 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
B10YD955QWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2741371Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5025c99f-b946-e2e0-e063-6394a90a13fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-271-15POLY-HIST DM15 mL in 1 BOTTLELIQUID151
50991-271-16POLY-HIST DM473 mL in 1 BOTTLELIQUID4731

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 96 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vapor StickCAMPHOR/MENTHOLRejoice International Corp.33d1fbf3-d33c-58b9-e063-6294a90ae0982025-10-13WarningsExact identifier
application number: M012
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCdb81e32b-0cad-400b-8479-a3b51de92b122025-10-10WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852b77ae-a5ac-3ead-e053-2a91aa0a54bd2025-10-09WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp8503c956-42a5-7684-e053-2991aa0adb272025-10-09WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852ceea2-d6a1-6de2-e053-2a91aa0ad50d2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852d5f01-9289-5515-e053-2a91aa0acf322025-10-09WarningsExact identifier
application number: M012
Giltuss Diabetic Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp85183b38-ce2a-0e0e-e053-2991aa0a336f2025-10-09WarningsExact identifier
application number: M012
Giltuss MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp8518fd91-981e-de78-e053-2a91aa0afcb22025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
application number: M012
Giltuss Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp85065cf3-386d-22d5-e053-2a91aa0a72da2025-10-09WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8b2c847-25e9-8714-e053-2995a90a73ce2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c5027f-9701-fb07-e053-2a95a90a60292025-10-09WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8c052d8-fb9f-09f2-e053-2a95a90a37af2025-10-09WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINGil Pharmaceutical Corpa8c53c14-ba82-2c68-e053-2a95a90a98942025-10-09WarningsExact identifier
application number: M012
Giltuss Severe SinusOXYMETAZOLINE HCLGil Pharmaceutical Corpab7fae3b-1f7d-5d0f-e053-2a95a90a148e2025-10-09WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRGil Pharmaceutical Corpa8c08532-1169-6603-e053-2a95a90a34842025-10-09WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINGil Pharmaceutical Corpa8c59e6d-c11c-2664-e053-2a95a90a83332025-10-09WarningsExact identifier
application number: M012
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741371dexchlorpheniramine maleate 1 MG / dextromethorphan HBr 10 MG in 5 mL Oral SolutionPSN5025c99f-b946-e2e0-e063-6394a90a13fb1
2741371dexchlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 2 MG/ML Oral SolutionSCD5025c99f-b946-e2e0-e063-6394a90a13fb1
2741371dexchlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 10 MG per 5 mL Oral SolutionSY5025c99f-b946-e2e0-e063-6394a90a13fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50991-271-155099102711515 mL in 1 BOTTLE (50991-271-15) 15 ml2026-04-23NoNoCurrent
50991-271-1650991027116473 mL in 1 BOTTLE (50991-271-16) 473 ml2026-04-23NoNoCurrent