Home NDC 55758-385 SanaTos
Product NDC 55758-385
11-digit product format 557580385
Labeler code 55758
Product ID 55758-385_4873c00c-3edf-844a-e063-6394a90ac80d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Pharmadel LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-31
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 25; 10; 650 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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
Brand name suffix Severe Cold Relief Nighttime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 ACETAMINOPHEN 650 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup 04JA59TNSJ Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659960 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-385-06 SanaTosSevere Cold Relief Nighttime 6 in 1 CARTON GRANULE, FOR SOLUTION 6 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-385 SANATOS SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 7 Current NDC, 1 package rows 20240331_144aafcc-6ec2-a322-e063-6294a90afc27.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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55758-385-06 55758038506 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-385-06) 2024-03-31 No No Current