FDA.reportPublic FDA data

HealthMart Chest Congestion Relief

Product NDC
62011-0060
11-digit product format
620110060
Labeler code
62011
Product ID
62011-0060_17b6ab25-42c0-441c-b0fb-8e7d45821c11
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-01
Substance
GUAIFENESIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
HealthMart Chest Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359601Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5d1a8e8-10ba-4fff-b6f7-18c0fde5155cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0060-1HealthMart Chest Congestion Relief1 in 1 CARTONTABLET14
62011-0060-1HealthMart Chest Congestion Relief50 in 1 BOTTLETABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0060-1EA - Each62011-006040c8027a-5e46-4884-8791-a5276b8321c312014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQHEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1
GuaifenesinACTIVE MOIETY495W7451VQHEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BHEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0060HEALTHMART CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241220_a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c.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 93 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VANACOF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGM Pharmaceuticals, INC2ed699f2-d004-4fa9-8042-6c85a9ff69b62025-11-03WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLVERITYRX, LLC42a05f69-0599-5571-e063-6394a90a37d32025-11-02WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpc296efd0-5030-4a26-a9b0-e66423d995dc2025-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Max Maximum Strength SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates, LLCf7ebe482-cb22-4517-8463-3432cf60071d2025-10-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Max SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates, LLC787bff76-0ee2-4e7e-b908-876e4a3e3bfc2025-10-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLTrader Joe's Company647dadae-f37a-8399-e053-2991aa0aedb32025-10-31WarningsExact identifier
application number: M012
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40416ff5-06e1-97dd-e063-6394a90a20462025-10-30WarningsExact identifier
application number: M012
Robitussin Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC44feee2f-25bc-48d4-8e13-db1d9daaaa902025-10-30WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb3d02c91-8f79-4eb4-a378-1072474c572c2025-10-30WarningsExact identifier
application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCf1d022dd-c2ca-497f-87d5-9ef3e20e8ea72025-10-30WarningsExact identifier
application number: M012
EndalTRIPROLIDINE HCL, DEXTROMETHORPHAN HBRPoly Pharmaceuticals, Inc.fc5401e2-ed65-72e7-e053-6294a90a81f32025-10-30WarningsExact identifier
application number: M012
daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incc7cef266-46fc-49ab-a2e7-54fc562986592025-10-30WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDESAM'S WEST INC16592ad7-b7cb-0837-e063-6394a90ae0592025-10-29WarningsExact identifier
application number: M012
Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLSAFEWAY013b94a1-26c7-4371-981a-d1b9d7fd1c982025-10-29WarningsExact identifier
application number: M012
Better LivingPHENYLEPHRINE HYDROCHLORIDEBETTER LIVING BRANDS LLCaea0db7f-e01a-4d8e-9c20-4a5ef4a905d12025-10-29WarningsExact identifier
application number: M012
AXIM DayTime - Night Time 72 SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLCde9eb2d5-ba51-4637-e053-2995a90a04512025-10-29WarningsExact identifier
application number: M012
Dollar General Vapor SteamCAMPHOR (SYNTHETIC)DOLGENCORP, LLC86d0f3ac-1359-c2f9-e053-2a91aa0a35d02025-10-29WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d628b09-c257-4369-8ddb-47554d83c0d82025-10-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNa5d1a8e8-10ba-4fff-b6f7-18c0fde5155c4
359601guaifenesin 400 MG Oral TabletSCDa5d1a8e8-10ba-4fff-b6f7-18c0fde5155c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0060-1620110060011 BOTTLE in 1 CARTON (62011-0060-1) / 50 TABLET in 1 BOTTLE1 bottle2019-08-290000-00-00NoNoCurrent