FDA.reportPublic FDA data

Mucolyte

Product NDC
57237-359
11-digit product format
572370359
Labeler code
57237
Product ID
57237-359_ab35cca0-adaa-4e57-bd51-b29528cb8358
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-22
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
Mucolyte
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
e4091aaf-44e3-4701-9986-aff248a2f1b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-359-12Mucolyte118 mL in 1 BOTTLELIQUID1181
57237-359-16Mucolyte473 mL in 1 BOTTLELIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-359-12ML - Milliliter57237-359aa46343d-4ab1-42be-a72d-e8e5258dc8c012026-01-08
57237-359-16ML - Milliliter57237-359faaec639-f255-498e-8333-a18d14e1f40f12026-01-08

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 133 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenalif Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd94e7-1808-3bb3-e063-6294a90a41402024-12-03WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC31531f90-8933-46ab-b722-cb63e77386392024-12-03WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWINCO FOODS, LLCf45f3ab4-5e10-3004-e053-2a95a90a0cb42024-12-03WarningsExact identifier
application number: M012
good sense allergyDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.2861b801-e778-822d-e063-6394a90aa1a82024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCfe0cf681-f42c-430c-8429-f7ba4bc5a9762024-12-02WarningsExact identifier
application number: M012
Allergy MultisymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5a5aa2ee-51b7-4698-bb27-3fb9d01bbea52024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association0ea270b7-9c28-49fb-9615-c4afdbdbc8f12024-12-02WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC0955d856-cc4e-4ef2-8bc0-1a632a5b5f792024-12-02WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC40c9c90d-6c9e-40d0-921d-1fd34eff90bb2024-12-02WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3d068d30-9a00-49d7-bbe9-d6b53c19e86d2024-12-02WarningsExact identifier
application number: M012
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.76724432-ff3c-404f-ba1f-5af68e3ab8c42024-12-02WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.73d4fc82-8508-44f8-83ca-9f32c5cd847b2024-12-02WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
application number: M012
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
application number: M012
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNe4091aaf-44e3-4701-9986-aff248a2f1b81
310604guaifenesin 20 MG/ML Oral SolutionSCDe4091aaf-44e3-4701-9986-aff248a2f1b81
310604guaifenesin 100 MG per 5 ML Oral SolutionSYe4091aaf-44e3-4701-9986-aff248a2f1b81
310604guaifenesin 100 MG per 5 ML Oral SyrupSYe4091aaf-44e3-4701-9986-aff248a2f1b81
310604guaifenesin 200 MG per 10 ML Oral SolutionSYe4091aaf-44e3-4701-9986-aff248a2f1b81
310604guaifenesin 300 MG per 15 ML Oral SolutionSYe4091aaf-44e3-4701-9986-aff248a2f1b81
310604guaifenesin 400 MG per 20 ML Oral SolutionSYe4091aaf-44e3-4701-9986-aff248a2f1b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-359-1257237035912118 mL in 1 BOTTLE (57237-359-12) 118 ml2025-12-22NoNoCurrent
57237-359-1657237035916473 mL in 1 BOTTLE (57237-359-16) 473 ml2025-12-22NoNoCurrent