Home NDC 54838-101 Silafed
Product NDC 54838-101
11-digit product format 548380101
Labeler code 54838
Product ID 54838-101_d0cb36b5-ff55-4145-b295-0614d83fb1c3
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine hydrochloride and Triprolidine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Lannett Company, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1988-10-05
Marketing end 0000-00-00
Substance PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength 30 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Pseudoephedrine hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 Triprolidine hydrochloride ACTIVE INGREDIENT YAN7R5L890 SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 Triprolidine ACTIVE MOIETY 2L8T9S52QM SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 sucrose INACTIVE INGREDIENT C151H8M554 SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5 water INACTIVE INGREDIENT 059QF0KO0R SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [SILARX PHARMACEUTICALS, INC] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-101-40 54838010140 118 mL in 1 BOTTLE, PLASTIC (54838-101-40) 118 ml 1988-10-05 0000-00-00 No No Current 54838-101-70 54838010170 237 mL in 1 BOTTLE, PLASTIC (54838-101-70) 237 ml 1988-10-05 0000-00-00 No No Current