Home NDC 36800-437-78 Topcare pain relief PM
Product NDC 36800-437
Requested package NDC 36800-437-78
11-digit product format 368000437
Labeler code 36800
Product ID 36800-437_d589a259-1459-489c-ac04-2cd702409279
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 1992-07-21
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-437-71 Topcare pain relief PMextra strength non habit forming 1 in 1 CARTON TABLET, FILM COATED 1 10 36800-437-71 Topcare pain relief PMextra strength non habit forming 50 in 1 BOTTLE TABLET, FILM COATED 50 10 36800-437-78 Topcare pain relief PMextra strength non habit forming 100 in 1 BOTTLE TABLET, FILM COATED 100 10 36800-437-78 Topcare pain relief PMextra strength non habit forming 1 in 1 CARTON TABLET, FILM COATED 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-437 TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 10 Legacy NDC, 4 package rows 20241217_4923b51c-a5b6-40ed-a0bd-fc29cdf68224.zip
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 36800-437-78 36800043778 1 BOTTLE in 1 CARTON (36800-437-78) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1992-07-21 0000-00-00 No No Current