FDA.reportPublic FDA data

Mucolyte

Product NDC
57237-360
Requested package NDC
57237-360-12
11-digit product format
572370360
Labeler code
57237
Product ID
57237-360_e0d8faa2-7ca9-49c9-bae0-138fea576c68
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-22
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
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
Brand name suffix
DM
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
c913d27d-bc00-4ace-9a5f-c55522e1cd1dAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-360-12MucolyteDM118 mL in 1 BOTTLELIQUID1181
57237-360-16MucolyteDM473 mL in 1 BOTTLELIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-360-12ML - Milliliter57237-360cd7cc154-3aa2-458a-862c-d765eca1df7312026-01-08
57237-360-16ML - Milliliter57237-3601bc9e866-3de7-4f28-b05c-54e2aac5c20012026-01-08

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 115 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Sugar freeDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.3a521b65-fb35-4cc3-b826-88513afda0f92025-05-16WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC51c7628a-c7cf-498f-8fb1-db732e2b8b6e2025-05-16WarningsExact identifier
application number: M012
BACTIMICINA CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDLC Laboratories, Inc.eaf554d4-a758-4ed6-bec5-d6cbfedae4082025-05-15WarningsExact identifier
application number: M012
Bactimicina Childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDLC Laboratories, Inc.d407a583-07ae-4d47-b15a-24b5865c82da2025-05-15WarningsExact identifier
application number: M012
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDERB Health (US) LLC35322238-d498-1a52-e063-6394a90ac9c42025-05-15WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCa1405038-80f2-45e5-bd8c-8c6b0ee348be2025-05-15WarningsExact identifier
application number: M012
Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIb919f0fe-fae0-4bd8-9ccd-d7569b2a70702025-05-13WarningsExact identifier
application number: M012
Childrens Robitussin Honey Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC6afaf85b-bf0c-4c99-acf3-a34f06be20f12025-05-13WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC77be57fb-0ae5-4fad-97f3-b6a4b57383a92025-05-13WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEBryant Ranch Prepackc948e612-a491-4ad0-adb9-cf31ef76e4d82025-05-12WarningsExact identifier
application number: M012
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDESafeway, Inc.c639a36d-c683-4a4d-90b7-eadec7464aa22025-05-08WarningsExact identifier
application number: M012
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
application number: M012
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy8296049c-72fc-4200-9d45-c8e377314cf22025-04-29WarningsExact 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 SolutionPSNc913d27d-bc00-4ace-9a5f-c55522e1cd1d1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc913d27d-bc00-4ace-9a5f-c55522e1cd1d1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc913d27d-bc00-4ace-9a5f-c55522e1cd1d1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYc913d27d-bc00-4ace-9a5f-c55522e1cd1d1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYc913d27d-bc00-4ace-9a5f-c55522e1cd1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-360-1257237036012118 mL in 1 BOTTLE (57237-360-12) 118 ml2025-12-22NoNoCurrent