FDA.reportPublic FDA data

Guaifenesin Syrup and Dextromethorphan

Product NDC
69339-149
11-digit product format
693390149
Labeler code
69339
Product ID
69339-149_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
2026-12-31

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
69339-149-05Guaifenesin Syrup and Dextromethorphan5 mL in 1 CUP, UNIT-DOSESYRUP56
69339-149-19Guaifenesin Syrup and Dextromethorphan10 in 1 TRAYSYRUP106
69339-149-19Guaifenesin Syrup and Dextromethorphan10 in 1 CASESYRUP106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-149GUAIFENESIN 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 21 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact identifier
application number: M012
Maximum Strength Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBRKROGER COMPANY30d4c4b9-0f5f-0279-e063-6394a90af1b52026-06-19WarningsExact identifier
application number: M012
GoodMeds Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.6a8a961c-d2d2-428d-8af7-8527aae25c8a2026-06-19WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI490766e7-1781-4b2b-a8f4-d4efb9fff5602026-06-19WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWALMART INC.30f6d588-ad80-4348-a45f-77337e067bca2026-06-19WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINCardinal Health 107, LLC888b6a2e-6631-4585-a7fe-eb122eb51b232026-06-18WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
application number: M012
Vaporizing Colds RubMENTHOLDelon Laboratories (1990) Ltd3ed8bc0c-c229-450b-a491-06b578c1b8ee2026-06-18WarningsExact identifier
application number: M012
Allergy ChildrensDIPHENHYDRAMINE HCLDOLGENCORP, LLC218c447e-9ddd-428a-9b33-0acec35e0d1b2026-06-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.a9d5f9f4-ddec-4ad6-ad06-4a612008bb682026-06-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Companye49d2a0f-6588-439b-8a46-c073e0bc4f9a2026-06-17WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafewayac0380ad-c9fa-4bda-ab84-c2e6aa672bdf2026-06-17WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
application number: M012
Tussin DM RegularDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.5460c809-71c8-3ad6-e063-6294a90a4e4f2026-06-16WarningsExact identifier
application number: M012
Equate Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.4b111580-cd20-43ec-9ff4-4b9f74f7d2e82026-06-16WarningsExact identifier
application number: M012
Sinus CongestionPHENYLEPHRINE HCLChain Drug Marketing Association, Inc.43a77f89-e66a-4db6-8067-f614c0e207df2026-06-16WarningsExact identifier
application number: M012
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact 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
69339-149-05693390149055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
69339-149-196933901491910 TRAY in 1 CASE (69339-149-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-149-05) 10 tray2020-10-190000-00-00NoNoCurrent