Home NDC 55758-384 SanaTos
Product NDC 55758-384
11-digit product format 557580384
Labeler code 55758
Product ID 55758-384_487431f0-067c-126f-e063-6394a90a0371
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, 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 ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base SanaTos
Brand name suffix Severe Cold and Cough Daytime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ Rxcui 1659967
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-384-06 SanaTosSevere Cold and Cough Daytime 6 in 1 CARTON GRANULE, FOR SOLUTION 6 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-384 SANATOS SEVERE COLD AND COUGH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 7 Current NDC, 1 package rows 20240331_14484bf5-ff45-b859-e063-6394a90a9a0f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55758-384-06 55758038406 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-384-06) 2024-03-31 No No Historical