FDA.reportPublic FDA data

Guaifenesin

Product NDC
60687-874
11-digit product format
606870874
Labeler code
60687
Product ID
60687-874_24b1b6f4-c113-8adc-e063-6394a90a546c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-20
Substance
GUAIFENESIN
Active strength
300 mg/15mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN300 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-874-16Guaifenesin10 in 1 CASESOLUTION101
60687-874-44Guaifenesin15 mL in 1 CUP, UNIT-DOSESOLUTION151
60687-874-50Guaifenesin10 in 1 TRAYSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-874-16ML - Milliliter60687-874eedfb90d-06ee-43b9-8eb9-013bd1ad669e12024-11-05
60687-874-44ML - Milliliter60687-874eaa67b25-76d7-46d7-a990-5e415e4d365e12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-874GUAIFENESIN SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20241021_2fd702ea-3069-472c-b99e-c527f1375705.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 20 MG/ML Oral SolutionSCD2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 100 MG per 5 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 100 MG per 5 ML Oral SyrupSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 200 MG per 10 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 300 MG per 15 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 400 MG per 20 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-874-166068708741610 TRAY in 1 CASE (60687-874-16) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-874-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-874-44) 10 tray2024-10-20NoNoHistorical
60687-874-446068708744415 mL in 1 CUP, UNIT-DOSE15 mlHistorical
60687-874-506068708745010 in 1 TRAYHistorical