Home NDC 29485-7003-2 TYLENOL Acetaminophen Extra Strength
Product NDC 29485-7003
Requested package NDC 29485-7003-2
11-digit product format 294857003
Labeler code 29485
Product ID 29485-7003_e42a3015-18e1-0c56-e053-2a95a90ad743
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, COATED
Route ORAL
Labeler Mechanical Servants, LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1984-08-19
Marketing end 0000-00-00
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Carnauba Wax INACTIVE INGREDIENT R12CBM0EIZ TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Castor oil INACTIVE INGREDIENT D5340Y2I9G TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Powdered Cellulose INACTIVE INGREDIENT SMD1X3XO9M TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Shellac INACTIVE INGREDIENT 46N107B71O TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [MECHANICAL SERVANTS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29485-7003 TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.] 16 Legacy NDC 20241101_68bb463c-91af-4eca-b2d5-9d134a756a45.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 29485-7003-2 29485700302 30 POUCH in 1 BOX (29485-7003-2) > 2 TABLET, COATED in 1 POUCH 30 pouch 1984-08-19 0000-00-00 No No Current