FDA.reportPublic FDA data

Cough Out

Product NDC
58593-255
11-digit product format
585930255
Labeler code
58593
Product ID
58593-255_37db956a-258a-9804-e063-6394a90aa2b4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Efficient Laboratories Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-07-01
Marketing end
2026-10-31
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cough Out

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604, 1099024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58593-255-042020-02-16C16284748780-19d75b9d0-f934-f424-e053-dadaa90a57ceCough Out
58593-255-062020-02-16C16284748780-19d75b9d0-f934-f424-e053-dadaa90a57ceCough Out
58593-255-042020-01-31C16284748780-19d75b9d0-f934-f424-e053-dadaa90a57ceCough Out
58593-255-062020-01-31C16284748780-19d75b9d0-f934-f424-e053-dadaa90a57ceCough Out

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-255-04Cough Out118 mL in 1 BOTTLELIQUID1189
58593-255-06Cough Out178 mL in 1 BOTTLELIQUID1789

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
HONEYINACTIVE INGREDIENTY9H1V576FHCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58593-255COUGH OUT (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC.]8Current NDC, Legacy NDC, 2 package rows20241016_fe4c3921-8d30-4cd6-ba90-9211b362a38a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099024Cough Out 100 MG in 5 mL Oral SolutionPSNfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNfe4c3921-8d30-4cd6-ba90-9211b362a38a9
1099024guaifenesin 20 MG/ML Oral Solution [Cough Out]SBDfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaifenesin 20 MG/ML Oral SolutionSCDfe4c3921-8d30-4cd6-ba90-9211b362a38a9
1099024Cough Out 100 MG per 5 ML Oral SolutionSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9
1099024Cough Out 20 MG/ML Oral SolutionSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaifenesin 100 MG per 5 ML Oral SolutionSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaifenesin 100 MG per 5 ML Oral SyrupSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaifenesin 200 MG per 10 ML Oral SolutionSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaifenesin 300 MG per 15 ML Oral SolutionSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9
310604guaifenesin 400 MG per 20 ML Oral SolutionSYfe4c3921-8d30-4cd6-ba90-9211b362a38a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58593-255-0458593025504118 mL in 1 BOTTLE (58593-255-04) 118 ml1997-07-010000-00-00NoNoCurrent
58593-255-0658593025506178 mL in 1 BOTTLE (58593-255-06) 178 ml1997-07-012026-10-31NoNoCurrent