Home NDC 55758-010-06 SanaTos Severe Cold and Cough Day Time
Product NDC 55758-010
Requested package NDC 55758-010-06
11-digit product format 557580010
Labeler code 55758
Product ID 55758-010_a70979fb-c597-0e70-e053-2995a90ab78d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Pharmadel LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-02-20
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 Dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 Phenylephrine hydrochloride ACTIVE INGREDIENT 04JA59TNSJ SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 Acesulfame Potassium INACTIVE INGREDIENT 23OV73Q5G9 SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 aspartame INACTIVE INGREDIENT Z0H242BBR1 SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 FD&C blue NO. 1 INACTIVE INGREDIENT H3R47K3TBD SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 FD&C red NO. 40 INACTIVE INGREDIENT WZB9127XOA SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 maltodextrin INACTIVE INGREDIENT 7CVR7L4A2D SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 sucrose INACTIVE INGREDIENT C151H8M554 SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1 tribasic calcium phosphate INACTIVE INGREDIENT 91D9GV0Z28 SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-010 SANATOS SEVERE COLD AND COUGH DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) GRANULE, FOR SOLUTION [PHARMADEL LLC] 6 Legacy NDC 20241120_b995a0b2-898d-4a8f-b44f-097ae54e0ba5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55758-010-06 55758001006 6 GRANULE, FOR SOLUTION in 1 CARTON (55758-010-06) 2014-02-20 0000-00-00 No No Current