FDA.reportPublic FDA data

Dextromethorphan HBr and Guaifenesin Oral Solution

Product NDC
81033-103
11-digit product format
810330103
Labeler code
81033
Product ID
81033-103_2cee75e1-ee97-6129-e063-6394a90a03dd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin Oral Solution
Dosage form
LIQUID
Route
ORAL
Labeler
KESIN PHARMA CORPORATION
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-02
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Additional Listing Data#

Finished product
Yes
Brand name base
Dextromethorphan HBr and Guaifenesin Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN10 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 9D2RTI9KYH
Rxcui996520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-103-05Dextromethorphan HBr and Guaifenesin Oral Solution5 mL in 1 CUP, UNIT-DOSELIQUID53
81033-103-10Dextromethorphan HBr and Guaifenesin Oral Solution10 mL in 1 CUP, UNIT-DOSELIQUID103
81033-103-50Dextromethorphan HBr and Guaifenesin Oral Solution100 in 1 CASELIQUID1003
81033-103-51Dextromethorphan HBr and Guaifenesin Oral Solution100 in 1 CASELIQUID1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-103-05ML - Milliliter81033-10305022df2-becf-472c-847f-e6b263c0f25912025-01-14
81033-103-10ML - Milliliter81033-103caeafea8-7b93-4c06-ada0-124690d9531b12025-01-14
81033-103-50ML - Milliliter81033-1030e79ce48-2721-4f2a-8547-f57a93faf90d12025-01-14
81033-103-51ML - Milliliter81033-103d784e62e-43c5-47bb-8317-3233326558d312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-103DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION LIQUID [KESIN PHARMA CORPORATION]3Current NDC, 4 package rows20250131_284eae44-81bc-400c-e063-6394a90af446.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN284eae44-81bc-400c-e063-6394a90af4463
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD284eae44-81bc-400c-e063-6394a90af4463
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY284eae44-81bc-400c-e063-6394a90af4463
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY284eae44-81bc-400c-e063-6394a90af4463
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY284eae44-81bc-400c-e063-6394a90af4463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-103-05810330103055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-103-108103301031010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
81033-103-5081033010350100 CUP, UNIT-DOSE in 1 CASE (81033-103-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05) 2024-12-02NoNoCurrent
81033-103-5181033010351100 CUP, UNIT-DOSE in 1 CASE (81033-103-51) / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10) 2024-12-02NoNoCurrent