FDA.reportPublic FDA data

Guaifenesin DM

Product NDC
60687-817
11-digit product format
606870817
Labeler code
60687
Product ID
60687-817_1d755574-97e5-8933-e063-6294a90a1e61
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan
Dosage form
SYRUP
Route
ORAL
Labeler
American Health Packaging
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-04
Substance
DEXTROMETHORPHAN; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7355X3ROTS, 495W7451VQ
Rxcui996520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-817-17Guaifenesin DM10 in 1 CASESYRUP101
60687-817-40Guaifenesin DM5 mL in 1 CUP, UNIT-DOSESYRUP51
60687-817-46Guaifenesin DM10 in 1 TRAYSYRUP101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-817-17ML - Milliliter60687-817b765be76-0967-47ad-8b89-33d95e620a9612024-08-12
60687-817-40ML - Milliliter60687-8175b62ce17-f584-48ff-8643-04b3d311b71c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-817GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20240807_990906b3-c566-4f35-923c-060202ba48e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN990906b3-c566-4f35-923c-060202ba48e01
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD990906b3-c566-4f35-923c-060202ba48e01
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY990906b3-c566-4f35-923c-060202ba48e01
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY990906b3-c566-4f35-923c-060202ba48e01
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY990906b3-c566-4f35-923c-060202ba48e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-817-176068708171710 TRAY in 1 CASE (60687-817-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-817-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-817-40) 10 tray2024-08-04NoNoHistorical
60687-817-40606870817405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-817-466068708174610 in 1 TRAYHistorical