Home NDC 36800-477-75 Topcare Fiber Laxative
Product NDC 36800-477
Requested package NDC 36800-477-75
11-digit product format 368000477
Labeler code 36800
Product ID 36800-477_5debe075-becc-4110-a2a5-4dc2fd9bd710
Type HUMAN OTC DRUG
Nonproprietary name Calcium polycarbophil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1997-08-11
Marketing end 0000-00-00
Substance CALCIUM POLYCARBOPHIL
Active strength 625 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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM POLYCARBOPHIL ACTIVE INGREDIENT 8F049NKY49 TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 POLYCARBOPHIL ACTIVE MOIETY W25LM17A4W TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 CARAMEL INACTIVE INGREDIENT T9D99G2B1R TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOPCARE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-477-75 36800047775 90 TABLET, FILM COATED in 1 BOTTLE (36800-477-75) 1997-08-11 0000-00-00 No No Current