FDA.reportPublic FDA data

Childrens Chest Congestion Relief Grape

Product NDC
53943-511
11-digit product format
539430511
Labeler code
53943
Product ID
53943-511_821e5d82-0d59-4c10-bd7c-1064a55d6270
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-04
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-511-24e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-511-249bebd1f3094a…5416666fcb17…

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
Childrens Chest Congestion Relief Grape
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

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
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e5d245f-515c-4106-a855-fb97681b646aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-511-242020-12-31C16284748780-19d75b9d0-74dd-f424-e053-dadaa90a57ce3e5d245f-515c-4106-a855-fb97681b646a
53943-511-242020-01-31C16284748780-19d75b9d0-74dd-f424-e053-dadaa90a57ce3e5d245f-515c-4106-a855-fb97681b646a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-511-24Childrens Chest Congestion Relief Grape118 mL in 1 BOTTLELIQUID1186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-511CHILDRENS CHEST CONGESTION RELIEF GRAPE (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]5Current NDC, Legacy NDC, 1 package rows20241222_3e5d245f-515c-4106-a855-fb97681b646a.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 169 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
application number: M012
Theraflu Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCc0689223-5c90-4dbc-bbfa-f94e267504c32024-01-28WarningsExact identifier
application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact identifier
application number: M012
THERAFLU NIGHTTIME SEVERE COLD AND COUGHACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC5f7f6f70-0f36-4541-89f2-d953259cdb1e2024-01-28WarningsExact identifier
application number: M012
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGood Sensebb709377-7bb3-4931-a2b6-2443aee07c122024-01-26WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC721bfee2-0d3d-4d8b-beee-1ea83064d1c82024-01-23WarningsExact identifier
application number: M012
Sugar Free Cough Drops Honey LemonMENTHOLCardinal Health 110, Inc.fe90dc33-2815-8296-e053-6294a90ac1df2024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCardinal Health 110, Inc.fe91543e-a798-6399-e053-6394a90af5e52024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough Drops Black CherryMENTHOLCardinal Health 110, Inc.fe90cf63-d286-fa5e-e053-6394a90a77592024-01-19WarningsExact identifier
application number: M012
Cough Drops Menthol Honey LemonCOUGH DROPS MENTHOLCardinal Health 110, Inc.fe5b3f6d-2a2d-f322-e053-6394a90aba042024-01-19WarningsExact identifier
application number: M012
Cough Drops MentholMENTHOL COUGH DROPSCardinal Health 110, Inc.fe5b557e-a689-a32c-e053-6294a90aadbd2024-01-19WarningsExact identifier
application number: M012
Cough Drops CherryCHERRY FLAVOR COUGH DROPSCardinal Health 110, Inc.fe5b5e57-1368-c62b-e053-6294a90ae82c2024-01-19WarningsExact identifier
application number: M012
Leader Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
application number: M012
Cough and Congestion DM Sugar FreeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBest Choice (Valu Merchandisers Company)4656e60e-4733-45c1-bf55-d156e45085c62024-01-17WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLRugby Laboratories775f97c0-6f82-49a8-82ac-f1a73920c3ec2024-01-11WarningsExact identifier
application number: M012
SinuFrin NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Incf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae2024-01-11WarningsExact identifier
application number: M012
SinuFrin Plus NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals, Inc.99afe6a6-1350-49c6-9347-b7e531e359252024-01-11WarningsExact identifier
application number: M012
Childrens Tukol Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.85fe6f0f-41c8-44d3-a34a-355938da5f722024-01-11WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leaderad437177-08eb-4811-883f-ac543d5bc58c2024-01-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN3e5d245f-515c-4106-a855-fb97681b646a6
310604guaifenesin 20 MG/ML Oral SolutionSCD3e5d245f-515c-4106-a855-fb97681b646a6
310604guaifenesin 100 MG per 5 ML Oral SolutionSY3e5d245f-515c-4106-a855-fb97681b646a6
310604guaifenesin 100 MG per 5 ML Oral SyrupSY3e5d245f-515c-4106-a855-fb97681b646a6
310604guaifenesin 200 MG per 10 ML Oral SolutionSY3e5d245f-515c-4106-a855-fb97681b646a6
310604guaifenesin 300 MG per 15 ML Oral SolutionSY3e5d245f-515c-4106-a855-fb97681b646a6
310604guaifenesin 400 MG per 20 ML Oral SolutionSY3e5d245f-515c-4106-a855-fb97681b646a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-511-2453943051124118 mL in 1 BOTTLE (53943-511-24) 118 ml2015-02-040000-00-00NoNoCurrent