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 171 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Cough Mucus ReliefDEXTROMETHORPHANN HBR, GUAIFENESINDiscount Drug Mart2c27aca4-e1e2-419a-84c4-857718ca49da2023-12-29WarningsExact identifier
application number: M012
Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyde2b2e34-62a5-451f-ab68-531d1c9d4d822023-12-29WarningsExact identifier
application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bd2b016ee-5329-45bf-9d71-d626204169cf2023-12-29WarningsExact identifier
application number: M012
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDeMoulas Market Baskete92d2f64-9690-42d3-b787-cafade3a89992023-12-29WarningsExact identifier
application number: M012
Cold and Sinus Maxium StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basket6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2023-12-29WarningsExact identifier
application number: M012
Cold, Flu and Sore Throat Maxium StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketd98029c0-ccd9-47e1-996f-c7786cd4ecca2023-12-29WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC0f2be061-bd0a-4e62-b994-6d0768ea647a2023-12-29WarningsExact identifier
application number: M012
Tussin CF Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketc19b9997-4037-48f3-b905-86da421a292d2023-12-29WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.0239ada0-644d-4ef4-a3b8-df70246a3bc22023-12-21WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.a698502d-c1c5-41ca-8142-74338b834c8b2023-12-21WarningsExact identifier
application number: M012
Father Johns Cough Medicine PlusNASAL DECONGESTANTOakhurst Company8b8aab0f-251b-6bd8-e053-2995a90ad7482023-12-18WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBROakhurst Company8b8a249d-55af-cc98-e053-2995a90a431d2023-12-18WarningsExact identifier
application number: M012
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79d92d2-d73c-d44f-e053-2995a90a03d92023-12-15WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCL TABLETLil' Drug Store Products, Inc.e5339c39-1d66-b283-e053-2995a90a43172023-12-15WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBRHumco Holding Group, Inca7b0669f-8da1-5a44-e053-2995a90a84d92023-12-15WarningsExact identifier
application number: M012
Ephedrine HydrochlorideEPHEDRINE HYDROCHLORIDEWalgreen Companybcb81dc1-d854-30c0-e053-2a95a90a9fc72023-12-14WarningsExact identifier
application number: M012
Allergy, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
application number: M012
Circle K Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.a6a1e3d9-575c-4adf-beb6-c9719de55c672023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Sinus Severe, Circle KACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store products, Inc.e78c456f-f62e-596d-e053-2995a90a23972023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Max ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79f1a92-d8ea-e3f9-e053-2a95a90a2d372023-12-14WarningsExact 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