FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

Product NDC
85722-0001
11-digit product format
857220001
Labeler code
85722
Product ID
85722-0001_a2cca1a0-64ab-4650-beb5-1265425eac7b
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form
SYRUP
Route
ORAL
Labeler
KJD Pharma Private Limited
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 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
85722-0001-4DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN118 mL in 1 BOTTLESYRUP1181
85722-0001-6DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN473 mL in 1 BOTTLESYRUP4731
85722-0001-8DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN236 mL in 1 BOTTLESYRUP2361

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN8877bb8d-479f-4968-8033-5c269d449a461
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD8877bb8d-479f-4968-8033-5c269d449a461
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY8877bb8d-479f-4968-8033-5c269d449a461
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY8877bb8d-479f-4968-8033-5c269d449a461
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY8877bb8d-479f-4968-8033-5c269d449a461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85722-0001-485722000104118 mL in 1 BOTTLE (85722-0001-4) 118 ml2021-02-01NoNoHistorical
85722-0001-685722000106473 mL in 1 BOTTLE (85722-0001-6) 473 ml2021-02-01NoNoHistorical
85722-0001-885722000108236 mL in 1 BOTTLE (85722-0001-8) 236 ml2021-02-01NoNoHistorical