FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan

Product NDC
0904-7512
11-digit product format
009047512
Labeler code
0904
Product ID
0904-7512_7a9d1e3e-d1ad-4b40-9f77-6df15fecacc2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan
Dosage form
SYRUP
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE; 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

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0904-7512-41Guaifenesin and Dextromethorphan5 mL in 1 CUP, UNIT-DOSESYRUP54
0904-7512-70Guaifenesin and Dextromethorphan10 in 1 CASESYRUP104
0904-7512-70Guaifenesin and Dextromethorphan10 in 1 TRAYSYRUP104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7512-41ML - Milliliter0904-75129cdd17b4-83f5-4ebf-b719-12a23d2030e012025-03-04
0904-7512-70ML - Milliliter0904-7512367db5fb-c75b-41e4-8c2b-f37c3d5ae9cf12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7512GUAIFENESIN AND DEXTROMETHORPHAN SYRUP [MAJOR PHARMACEUTICALS]4Current NDC, 3 package rows20250211_97b137c9-0bec-409a-91f7-e298c296578b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN97b137c9-0bec-409a-91f7-e298c296578b4
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD97b137c9-0bec-409a-91f7-e298c296578b4
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY97b137c9-0bec-409a-91f7-e298c296578b4
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY97b137c9-0bec-409a-91f7-e298c296578b4
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY97b137c9-0bec-409a-91f7-e298c296578b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7512-41009047512415 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0904-7512-700090475127010 TRAY in 1 CASE (0904-7512-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7512-41) 10 tray2025-02-10NoNoHistorical