FDA.reportPublic FDA data

Family Wellness Chest Congestion Relief

Product NDC
55319-891
11-digit product format
553190891
Labeler code
55319
Product ID
55319-891_6eaa5b33-e190-4039-877d-70b6cf863d6c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Services Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-27
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
Family Wellness 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
412f3459-4c22-4822-86bd-011fc3e91ca6Available 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
55319-891-30Family Wellness Chest Congestion Relief30 in 1 BOTTLETABLET305
55319-891-30Family Wellness Chest Congestion Relief1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-891FAMILY WELLNESS CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [FAMILY DOLLAR SERVICES INC]5Current NDC, 2 package rows20241220_412f3459-4c22-4822-86bd-011fc3e91ca6.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 83 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Afrin No Drip Pump Mist Bundle PackOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.16c52c79-baec-87db-e063-6294a90a3b3b2025-12-04WarningsExact identifier
application number: M012
Afrin Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.0f5ec576-f788-40aa-9088-0dd672e3cc7c2025-12-04WarningsExact identifier
application number: M012
Adult Long Lasting Cough ReliefDEXTROMETHORPHAN HBRShield Pharmaceuticals Corp432a79a9-c69d-4514-894a-7832e1b745ef2025-12-04WarningsExact identifier
application number: M012
GENCONTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS69d16d25-b09b-430e-8e01-0962d840dc212025-12-04WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLH E B7c04ab14-af28-4598-90ef-56ac11902c7d2025-12-04WarningsExact identifier
application number: M012
Desgen PediatricDEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCLKramer Novis12425c1b-8bdc-446b-83dd-95e05a4d9b8c2025-12-04WarningsExact identifier
application number: M012
Presgen BDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5befa829-32bd-4978-8a0e-1d6513ff37a42025-12-03WarningsExact identifier
application number: M012
TUSSLINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKramer Novis987e19a5-032f-44e9-b4c7-8a764d5026952025-12-03WarningsExact identifier
application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.450e8974-8ff8-4b82-e063-6394a90a93662025-12-03WarningsExact identifier
application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store Products, Inc.4510223f-1c88-2796-e063-6394a90a18ac2025-12-03WarningsExact identifier
application number: M012
Carolina Crud CrusherDEXTROMETHORPHAN HBR, GUAIFENESINWeeks & Leo Co., Inc.0b606683-7d68-cca5-e063-6394a90a6f582025-12-03WarningsExact identifier
application number: M012
Capmist DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECapital Pharmaceutical, LLC63733ac3-859e-4a8e-8717-d852bd3034082025-12-03WarningsExact identifier
application number: M012
ALA-HIST IRDEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.0d203b5c-8b10-428b-8703-17be6b4ce6eb2025-12-03WarningsExact identifier
application number: M012
ALAHIST DMDEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.fdaa062d-110e-798d-e053-6394a90a755c2025-12-03WarningsExact identifier
application number: M012
Alahist DPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.a1b8533a-ef8b-57cc-e053-2995a90a5d9e2025-12-03WarningsExact identifier
application number: M012
Alahist PEDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.ada2d582-5813-2029-e053-2a95a90ae5672025-12-03WarningsExact identifier
application number: M012
Benadryl Allergy Extra Strength Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC30aca3ab-b091-3939-e063-6294a90a98192025-12-03WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRL.N.K. International, Inc.9f2daffc-1904-4d64-9f84-689c88601e062025-12-03WarningsExact identifier
application number: M012
Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.d291faa9-894e-421c-8115-8a8c2a9371722025-12-03WarningsExact identifier
application number: M012
SINUS PAIN AND CONGESTIONACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy697dffdd-5b56-4395-8e69-6b4360d9fdc52025-12-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN412f3459-4c22-4822-86bd-011fc3e91ca65
359601guaifenesin 400 MG Oral TabletSCD412f3459-4c22-4822-86bd-011fc3e91ca65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-891-30553190891301 BOTTLE in 1 CARTON (55319-891-30) / 30 TABLET in 1 BOTTLE1 bottle2023-09-14NoNoCurrent