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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact identifier
application number: M012
Equate Severe Cold Cough and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.a35531d7-1a96-45cb-922f-61db085cde1f2026-06-16WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company5fe9f313-d6e7-41f5-abfc-e4c72b7089612026-06-15WarningsExact identifier
application number: M012
Pain Relief Sinus CongestionACETAMINOPHEN, PHENYLEPHRINE HCLBetter Living Brands, LLC1d3d6397-0d92-4145-9a70-8bcc45bd03222026-06-15WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f112026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd5d9334d-3db6-4f45-ab84-3e1ec5a752c62026-06-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLGeiss, Destin & Dunn Inc.fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b2026-06-15WarningsExact identifier
application number: M012
equate daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWal-Mart Stores Inc983a4783-d826-41b6-8087-ca66bcd5b6ca2026-06-12WarningsExact identifier
application number: M012
Equate Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc4173ecde-a2d7-4836-a6e9-fef2270d1b4e2026-06-12WarningsExact identifier
application number: M012
PAIN RELIEVER PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)cf370a59-42d5-42fe-882f-09885c55f5702026-06-11WarningsExact identifier
application number: M012
Sudafed Sinus Congestion Plus Cold Severe DayACETAMINOPHEN, PSEUDOEPHEDRINEKenvue Brands LLC537e1a0d-820d-c3f7-e063-6294a90a56ea2026-06-10WarningsExact identifier
application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and NightACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINEKenvue Brands LLC5382dcad-0337-4440-e063-6394a90a706e2026-06-10WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.21cfa71c-7a8f-4100-a42e-9190260653d12026-06-09WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLWALGREENS47f1d92f-cb4b-1635-e063-6294a90a2c712026-06-09WarningsExact identifier
application number: M012
HALLS HoneyMENTHOLMondelez Global LLC837f5ded-8efb-402b-a1bc-b5c1427556602026-06-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc932b11b1-f4a0-417a-bfa1-05261a1721552026-06-08WarningsExact identifier
application number: M012
NO DRIP NASAL MISTOXYMETAZOLINE HYDROCHLORIDEKroger Company957efbcf-b6d3-4793-bb6e-27e99c9be9052026-06-08WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED493caecb-e687-49ea-b7a1-2a5b9376896d2026-06-08WarningsExact identifier
application number: M012
Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY4ad10fd7-c088-4356-9d34-a95cfe3a41332026-06-08WarningsExact identifier
application number: M012
Theraflu Severe Congestion Relief Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC4ec42064-7390-4137-a93e-57343c3c76a72026-06-08WarningsExact 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