FDA.reportPublic FDA data

Sunmark Chest Congestion Relief DM

Product NDC
49348-728
11-digit product format
493480728
Labeler code
49348
Product ID
49348-728_e436f142-3bfa-44a0-830f-78ae334c00dd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/1; mg/1
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

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
Sunmark Chest Congestion Relief DM
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147685Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10cad9a7-1223-470c-9027-807891217d40Available 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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-728-09Sunmark Chest Congestion Relief DMDM50 in 1 BOTTLETABLET504
49348-728-09Sunmark Chest Congestion Relief DMDM1 in 1 CARTONTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-728-09EA - Each49348-728fcd28cf5-8c80-490b-80ae-39e37843ee3e12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
GuaifenesinACTIVE INGREDIENT495W7451VQSUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
GuaifenesinACTIVE MOIETY495W7451VQSUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-728SUNMARK CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241220_10cad9a7-1223-470c-9027-807891217d40.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 94 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
application number: M012
Vapor StickCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.33e259d6-b065-a677-e063-6394a90ab3142025-10-23WarningsExact identifier
application number: M012
Severe Nighttime Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy1ec3fc79-4f38-439f-99be-646b82231aa52025-10-23WarningsExact identifier
application number: M012
RycontussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories, Inc41afb883-1158-9764-e063-6294a90a17122025-10-21WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine MaleateACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATECVS Pharmacy, Inc1532ee21-e114-ded7-e063-6294a90ab0252025-10-21WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC1539c3d4-d982-7d4e-e063-6394a90ad7d62025-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEMethod Pharmaceuticals, LLC5a60c923-8bb7-427f-9636-08ed5474f71b2025-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICE97ed70a0-b692-4c12-90d6-72b3c87e554c2025-10-21WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI311e2b6b-21cb-4b4c-a78d-a0732d29602f2025-10-21WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI13910ea1-37dd-43bb-9fe8-e843f59201b72025-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAmerisource Bergend6f185b6-8538-4eac-98da-83760c34b4882025-10-20WarningsExact identifier
application number: M012
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
application number: M012
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)DIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.4157e680-37ac-eb4c-e063-6394a90a2a992025-10-17WarningsExact identifier
application number: M012
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED92c570ff-139f-49ff-a7bd-8a540ecc07c72025-10-17WarningsExact identifier
application number: M012
NoHist DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.6aafe912-28ff-442f-8e07-b3c5993ac9432025-10-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN10cad9a7-1223-470c-9027-807891217d404
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD10cad9a7-1223-470c-9027-807891217d404
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY10cad9a7-1223-470c-9027-807891217d404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-728-09493480728091 BOTTLE in 1 CARTON (49348-728-09) / 50 TABLET in 1 BOTTLE1 bottle2019-08-290000-00-00NoNoCurrent