Home NDC 68016-029 Extra Strength Pain Relief
Product NDC 68016-029
11-digit product format 680160029
Labeler code 68016
Product ID 68016-029_ed74927d-d5f0-279c-e053-2995a90add78
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2007-09-01
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 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 · 42 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 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-029-14 68016002914 1 BOTTLE in 1 CARTON (68016-029-14) > 50 TABLET, COATED in 1 BOTTLE 1 bottle 2007-09-01 0000-00-00 No No Current 68016-029-20 68016002920 1 BOTTLE in 1 CARTON (68016-029-20) > 100 TABLET, COATED in 1 BOTTLE 1 bottle 2007-09-01 0000-00-00 No No Current 68016-029-47 68016002947 400 TABLET, COATED in 1 BOTTLE (68016-029-47) 2007-09-01 0000-00-00 No No Current