FDA.reportPublic FDA data

SanaTos Mucus Relief Cold Toddlers

Product NDC
55758-307
11-digit product format
557580307
Labeler code
55758
Product ID
55758-307_2d58d9b1-2c02-42e2-e063-6294a90a205c
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Pharmadel LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-17
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
50; 2.5 mg/2.5mL; mg/2.5mL
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
SanaTos Mucus Relief Cold Toddlers
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN50 mg/2.5mL
DEXTROMETHORPHAN HYDROBROMIDE2.5 mg/2.5mL

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
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60672feb-1421-651e-e053-2a91aa0af41dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-307-02SanaTos Mucus Relief Cold Toddlers59 mL in 1 BOTTLE, WITH APPLICATORLIQUID596

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-307SANATOS MUCUS RELIEF COLD TODDLERS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [PHARMADEL LLC]6Current NDC, Legacy NDC, 1 package rows20250210_60672feb-1421-651e-e053-2a91aa0af41d.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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
application number: M012
Medi-First Plus Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDESportpharm LLC20f58b0b-c123-477f-a62c-fa5423e23f932026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLSportpharm LLC7f4e8d37-8c6b-4849-b86c-4335a0bcac1c2026-03-06WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu KitDAYTIME AND NIGHTTIME COLD AND FLU KITAllegiant Health0533db78-7809-46ea-9998-deb5f6f1d0d92026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLBetter Living Brands, LLC0153294d-7f52-4d92-8db8-daeca3e29a3b2026-03-06WarningsExact identifier
application number: M012
Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution, Inc.87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e2026-03-06WarningsExact identifier
application number: M012
RYNEX PEBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLEDWARDS PHARMACEUTICALS, INC.77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef2026-03-05WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)042f9449-4af0-4b15-bb3e-236afeb1e11f2026-03-05WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINAmerisource Bergen087a3a0b-8d3f-45ed-8807-0af47b446cac2026-03-05WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGNUVICARE LLC6c4bc7d1-09d9-4311-8457-a1d47ab02a5a2026-03-05WarningsExact identifier
application number: M012
Allergy Relief childrensDIPHENHYDRAMINE HCLWALMART INC.dceb99a9-4aa3-4acc-b632-9a4ba8c879192026-03-04WarningsExact identifier
application number: M012
AMAZON Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMAZON.COM SERVICES LLC26101105-a6cf-4b51-a639-9d078542fea32026-03-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLMajor Pharmaceuticals3a976e90-c6af-4414-984e-9987158c9e982026-03-04WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)714e93ec-0aa9-4be2-9311-399e82f148e02026-03-04WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAMAZON.COM SERVICES LLC6bbe8cc9-7a60-4476-b5cf-b13c5bebff262026-03-04WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5a1dfaf3-370d-4ac7-a72d-a48863a357412026-03-04WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN60672feb-1421-651e-e053-2a91aa0af41d6
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD60672feb-1421-651e-e053-2a91aa0af41d6
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY60672feb-1421-651e-e053-2a91aa0af41d6
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY60672feb-1421-651e-e053-2a91aa0af41d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-307-025575803070259 mL in 1 BOTTLE, WITH APPLICATOR (55758-307-02) 59 ml2017-10-170000-00-00NoNoCurrent