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 34 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids AllergyDIPHENHYDRAMINE HCLGenexa Inc.a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec42026-05-08WarningsExact identifier
application number: M012
day time non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Incf4fd597f-bca2-4ed4-b353-6c734f2f885c2026-05-08WarningsExact identifier
application number: M012
Daytime Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyd8339bb0-5da3-4f34-a819-339643cf4a972026-05-08WarningsExact identifier
application number: M012
severe tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa26afc33-533e-4dc0-ab25-21be87356e222026-05-08WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketcdd53eba-1fa2-49c1-b03d-c32f309da7fb2026-05-08WarningsExact identifier
application number: M012
Benadryl Allergy Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLH E B6503761f-37ae-4f39-b727-cb75d4c4a3c92026-05-07Warnings, Adverse reactionsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLCad199488-a4be-4b6e-b806-67ce8a6e907e2026-05-07WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HCLL. Perrigo Company5d42adb9-3625-4072-a6b1-29a229f255c82026-05-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company4856cd7b-ccdf-4546-9c65-236ebaac3dca2026-05-06WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac2026-05-06WarningsExact identifier
application number: M012
daytime cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED175cc2d0-0202-4e38-8af2-9fc126b7412d2026-05-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals90fae0fa-da07-4ea8-bdbd-39c2ed99ae592026-05-06WarningsExact identifier
application number: M012
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals5d8b980f-0011-41e3-a881-ad10fe3990792026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC38d12374-e2c7-444c-e063-6294a90a42b32026-05-06WarningsExact identifier
application number: M012
HALLS MentholyptusMENTHOLMondelez Global LLC1ab295ff-94b1-c938-e063-6294a90a98fd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.512af63d-2f09-4baa-e063-6394a90a86bd2026-05-06WarningsExact identifier
application number: M012
Thieves Chest RubCHEST RUBYoung Living Essential Oils, LC.9b7f125e-6caa-c53e-e053-2a95a90a737e2026-05-06WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Plus Pain and HeadacheACETAMINOPHEN, GUAIFENESINShield Pharmaceuticals Corpf20c0db1-dcf3-4bfc-b3e4-930398f82dc92026-05-06WarningsExact identifier
application number: M012
NitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc8aa6492b-1723-4c6b-82ee-4f800301c6ad2026-05-06WarningsExact 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