Home NDC 36800-355-71 Topcare Headache PM Formula
Product NDC 36800-355
Requested package NDC 36800-355-71
11-digit product format 368000355
Labeler code 36800
Product ID 36800-355_c0337d33-a5de-4045-be54-dd4c66b8b7e8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1997-08-25
Marketing end 2021-02-28
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE HEADACHE PM FORMULA (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-355-71 36800035571 1 BOTTLE in 1 CARTON (36800-355-71) > 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1997-08-25 2021-02-28 No No Current