Home NDC 36800-227-78 Topcare Pain Relief
Product NDC 36800-227
Requested package NDC 36800-227-78
11-digit product format 368000227
Labeler code 36800
Product ID 36800-227_38445864-ca98-4971-81d5-586436459105
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2006-04-14
Marketing end 0000-00-00
Substance ACETAMINOPHEN
Active strength 500 mg/1
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-227-78 36800022778 1 BOTTLE in 1 CARTON (36800-227-78) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2006-04-14 0000-00-00 No No Current