FDA.reportPublic FDA data

Guaifenesin Syrup and Dextromethorphan

Product NDC
69339-150
11-digit product format
693390150
Labeler code
69339
Product ID
69339-150_6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin Syrup and Dextromethorphan
Dosage form
SYRUP
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-19
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
100; 10 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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin Syrup and Dextromethorphan
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad9026f4-f0b6-4d02-aa44-f0460eeefc0eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-150-01Guaifenesin Syrup and Dextromethorphan10 mL in 1 CUP, UNIT-DOSESYRUP106
69339-150-19Guaifenesin Syrup and Dextromethorphan10 in 1 TRAYSYRUP106
69339-150-19Guaifenesin Syrup and Dextromethorphan10 in 1 CASESYRUP106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-150GUAIFENESIN SYRUP AND DEXTROMETHORPHAN SYRUP [NATCO PHARMA USA LLC]6Current NDC, Legacy NDC, 3 package rows20231102_ad9026f4-f0b6-4d02-aa44-f0460eeefc0e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 66 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier ValueCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2de803-900d-02f4-e063-6394a90a84cc2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMON SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307f3a7-f6e7-8a5d-e063-6394a90ab7eb2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2e8fbe-c1c3-79b1-e063-6394a90a4d732025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2dfcc3-e599-3102-e063-6394a90ad54a2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2ead3c-b4d5-ee8f-e063-6294a90a3c392025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f42644-045b-c4b3-e063-6294a90a48fd2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f45499-bf14-03e4-e063-6394a90a535c2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3ddcc-9d4e-f1b1-e063-6294a90ac86f2025-12-29WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a5551-4989-d8fe-e063-6394a90aeabf2025-12-29WarningsExact identifier
application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough DropsMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2acaa-2cc8-a999-e063-6294a90a15ce2025-12-29WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a92ecc-6a9c-b569-e063-6394a90a8bcb2025-12-29WarningsExact identifier
application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.a5ceab90-6885-4f3a-b001-97679e03c01b2025-12-29WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINLlorens Pharmaceutical International Division, Inc.77c16288-68c4-476c-995f-86f5056632702025-12-29WarningsExact identifier
application number: M012
Tusnel DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.fe457e6d-422d-496c-bcb9-33594f3c42ff2025-12-29WarningsExact identifier
application number: M012
Tusnel DiabeticDEXTROMETHORPHAN, GUAIFENESINLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION66b3c094-809e-4d2c-bc15-46563de685cb2025-12-29WarningsExact identifier
application number: M012
FortifyMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
application number: M012
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012
Winco Foods Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLWinCo Foods, LLCf54eb60d-c602-1272-e053-2995a90aa95a2025-12-28WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNad9026f4-f0b6-4d02-aa44-f0460eeefc0e6
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDad9026f4-f0b6-4d02-aa44-f0460eeefc0e6
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYad9026f4-f0b6-4d02-aa44-f0460eeefc0e6
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYad9026f4-f0b6-4d02-aa44-f0460eeefc0e6
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYad9026f4-f0b6-4d02-aa44-f0460eeefc0e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-150-016933901500110 mL in 1 CUP, UNIT-DOSE10 mlHistorical
69339-150-196933901501910 TRAY in 1 CASE (69339-150-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-150-01) 10 tray2020-10-190000-00-00NoNoCurrent