FDA.reportPublic FDA data

Guaifenesin

Product NDC
58657-509
11-digit product format
586570509
Labeler code
58657
Product ID
58657-509_41b52068-d18f-5c54-e063-6394a90aa503
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-09
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
312ce620-4841-7488-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-509-16Guaifenesin473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-509-16ML - Milliliter58657-5093ae23965-f0cf-41d6-95fe-ed03df86f2e112016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-509GUAIFENESIN LIQUID [METHOD PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 1 package rows20241201_312ce620-4841-7488-e054-00144ff88e88.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 170 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012
AXIM DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC0e7424ea-461f-5ead-e063-6294a90a41b62024-01-05WarningsExact identifier
application number: M012
AXIM Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC0e740063-80d5-c48b-e063-6394a90a3b302024-01-05WarningsExact identifier
application number: M012
AXIM DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC0e742e10-daea-6443-e063-6294a90ab5af2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3c3e0dc8-cddd-4f46-9b68-19bac00c07cc2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLA-S Medication Solutionsfa12a5a8-bf2d-4991-9d54-9c519e8e04cd2024-01-04WarningsExact identifier
application number: M012
NASAL DECONGESTANT PE 10mgPHENYLPHRINE HCLYYBA CORP05824fc4-ef3f-4ebb-b601-252f76ad60ef2024-01-03WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP5943d975-77e4-4cbd-b2d9-d699052fe82a2024-01-01WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEProficient Rx LPac79a7dd-c26e-47d2-8fb9-768d2d09e5072024-01-01WarningsExact identifier
application number: M012
Oxymethazoline HCLOXYMETHAZOLINE HCLProficient Rx LP96883e5f-18b5-4c1c-b984-756cb86be6ff2024-01-01WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP6e91b9c3-57e8-488b-ac70-d863cdf9d6e82024-01-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LP9e067482-8735-4476-a82e-438dd24d42892024-01-01WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.94e02be4-b8a6-422a-8f66-e6a69e924b2c2023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDEAptaPharma Inc.8a4c55d0-c472-4e89-9fdb-17ecf0af48562023-12-30WarningsExact identifier
application number: M012
XL-3 XtremeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAptaPharma Inc.dff79e0b-edf0-4dd3-a722-fd9beecd62932023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSalado Sales, Inc.e25727d0-7dd7-4ef5-b064-7938679f075f2023-12-29WarningsExact identifier
application number: M012
Maximum Strength DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E Bbb56d09d-ecb0-469e-a16f-f9f1a48942a82023-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN312ce620-4841-7488-e054-00144ff88e889
310604guaifenesin 20 MG/ML Oral SolutionSCD312ce620-4841-7488-e054-00144ff88e889
310604guaifenesin 100 MG per 5 ML Oral SolutionSY312ce620-4841-7488-e054-00144ff88e889
310604guaifenesin 100 MG per 5 ML Oral SyrupSY312ce620-4841-7488-e054-00144ff88e889
310604guaifenesin 200 MG per 10 ML Oral SolutionSY312ce620-4841-7488-e054-00144ff88e889
310604guaifenesin 300 MG per 15 ML Oral SolutionSY312ce620-4841-7488-e054-00144ff88e889
310604guaifenesin 400 MG per 20 ML Oral SolutionSY312ce620-4841-7488-e054-00144ff88e889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-509-1658657050916473 mL in 1 BOTTLE (58657-509-16) 473 ml2016-02-090000-00-00NoNoCurrent