Home NDC 54838-145 Infants Silapap
Product NDC 54838-145
11-digit product format 548380145
Labeler code 54838
Product ID 54838-145_badd004e-0f97-426a-825f-606b3e1ab63e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Lannett Company, Inc.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1997-04-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN
Active strength 80 mg/.8mL
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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 Acetaminophen ACTIVE MOIETY 362O9ITL9D INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 methylparaben INACTIVE INGREDIENT A2I8C7HI9T INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 saccharin sodium dihydrate INACTIVE INGREDIENT SB8ZUX40TY INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 water INACTIVE INGREDIENT 059QF0KO0R INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 14 Acetaminophen ACTIVE INGREDIENT 362O9ITL9D INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 water INACTIVE INGREDIENT 059QF0KO0R INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-145-15 54838014515 15 mL in 1 BOTTLE, DROPPER (54838-145-15) 15 ml 1997-04-01 0000-00-00 No No Current 54838-145-30 54838014530 30 mL in 1 BOTTLE, DROPPER (54838-145-30) 30 ml 1997-04-01 0000-00-00 No No Current