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
Ingredient	Strength
GUAIFENESIN	50 mg/2.5mL
DEXTROMETHORPHAN HYDROBROMIDE	2.5 mg/2.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020138	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
60672feb-1421-651e-e053-2a91aa0af41d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-307-02	SanaTos Mucus Relief Cold Toddlers	59 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	59		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-307	SANATOS MUCUS RELIEF COLD TODDLERS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [PHARMADEL LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250210_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 157 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	dbc71f58-0704-4d2b-aed1-0dc01f980006	2024-06-11	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	TARGET CORPORATION	135d2212-2122-b7a1-e063-6294a90aa5f5	2024-06-07	Warnings	Exact identifier application number: M012
up and up daytime honey cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	29da4b94-8f8e-48e8-909f-8476e3b39d78	2024-06-06	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	TARGET Corporation	e3da3003-88e3-4431-8b65-e61e17728901	2024-06-04	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE	Foundation Consumer Healthcare	15c3570c-bd00-8e43-e063-6294a90a8683	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Healthcare	176be362-5237-edd8-e063-6294a90a4aef	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	179115ad-d610-99b2-e063-6294a90ae711	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Healthcare	179259a9-231e-df03-e063-6294a90a145e	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough	BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Healthcare	1820e7c7-bc11-9061-e063-6394a90ae581	2024-06-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	682c5a4b-5ded-4276-903f-1ef1141ae518	2024-06-01	Warnings	Exact identifier application number: M012
Maximum Strength Nasal Decongestant	OXYMETAZOLINE SPRAY	CVS Health	df1f8bda-7bf3-4755-9169-f2a81d824cbe	2024-05-31	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	a78d29ed-019b-4014-ae6f-c60c75d19c89	2024-05-31	Warnings	Exact identifier application number: M012
Leader Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Cardinal Health 110,Inc	6594c117-6ffc-4bda-8bbf-e91c810f2c3f	2024-05-31	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	1aba9b7c-8328-4a9f-8ce2-39648b2d8ae4	2024-05-23	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	fdf63308-fe7b-4613-a012-ed5e4c9f8ffe	2024-05-23	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	e61ab02d-f932-403f-a4f7-0ca354607223	2024-05-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	e4f9a846-ab72-4508-b0c5-f7911af2f3d7	2024-05-23	Warnings	Exact identifier application number: M012
Adult Cough Relief	DEXTROMETHORPHAN HBR	QUALITY CHOICE (Chain Drug Marketing Association)	6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c	2024-05-20	Warnings	Exact identifier application number: M012
Chlorpheniramine Maleate 4 mg	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	54681242-c861-4415-b5c0-d3ab55b62be1	2024-05-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	60672feb-1421-651e-e053-2a91aa0af41d	6
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	60672feb-1421-651e-e053-2a91aa0af41d	6
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	60672feb-1421-651e-e053-2a91aa0af41d	6
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	60672feb-1421-651e-e053-2a91aa0af41d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55758-307-02	55758030702	59 mL in 1 BOTTLE, WITH APPLICATOR (55758-307-02)	59 ml	2017-10-17	0000-00-00	No	No	Current