Home NDC 36800-478 Topcare Antacid Calcium
Product NDC 36800-478
11-digit product format 368000478
Labeler code 36800
Product ID 36800-478_43115b32-1936-20e8-e063-6294a90a1389
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Topco Associates LLC.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-15
Substance CALCIUM CARBONATE
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-478-47 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-478-47 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 36800-478-47 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 36800-478-47 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 36800-478-47 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 36800-478-47 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 36800-478-47 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 36800-478-47 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 36800-478-47 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 36800-478-47 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 36800-478-47 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 36800-478-47 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topcare Antacid Calcium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308907 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-478-48 Topcare Antacid Calcium 150 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 150 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-478 TOPCARE ANTACID CALCIUM (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC.] 10 Current NDC, Legacy NDC, 1 package rows 20241107_bb99b942-1f84-43e1-a18d-3a975cddc59e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 36 · 719 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rolaids Ultra Strength Antacid Strawberry CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. f4a91efc-2d81-4605-8178-d36ab6c71563 2026-01-14 Warnings Exact identifier application number: M001 D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PURO SODIUM BICARBONATE Evi Labs 485f9eb1-6535-c47c-e063-6394a90ae32c 2026-01-14 Warnings Exact identifier application number: M001 Rolaids Extra Strength Fruit CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. ce2af1a6-0387-41e5-ad06-85b790bd4120 2026-01-14 Warnings Exact identifier application number: M001 Rolaids Ultra Strength Mint CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. 8806c912-ab83-4f45-ac78-e826bb3143d4 2026-01-14 Warnings Exact identifier application number: M001 Rolaids Advanced Antacid Anti-gas Wild Berry CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONE Chattem, Inc. 07649a83-0123-4bb5-b130-3067c7d052c5 2026-01-14 Warnings Exact identifier application number: M001 CVS Health Extra Strength Sugar Free Antacid ANTACID CVS Pharmacy,Inc. f722e7ce-6cca-4850-a230-7510c7ca7754 2026-01-12 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Assorted Fruits CALCIUM CARBONATE Medical Group Care LLC 47e1a46c-5665-ac4c-e063-6294a90a9b81 2026-01-08 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Assorted Fruits CALCIUM CARBONATE Medical Group Care LLC 47e19b30-3784-ad98-e063-6294a90aa566 2026-01-08 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Tropical Fruit CALCIUM CARBONATE Medical Group Care LLC 47e1bc32-baf5-ad9a-e063-6294a90ad5b4 2026-01-08 Warnings Exact identifier application number: M001 MGC Health Calcium Carbonate Antacid Assorted Berries CALCIUM CARBONATE Medical Group Care LLC 47e1c7c7-4f3b-c04b-e063-6394a90a775f 2026-01-08 Warnings Exact identifier application number: M001 Sanar Baking Soda 8oz 100% pure SODIUM BICARBONATE Evi Labs 47e7f801-3176-288c-e063-6394a90abef4 2026-01-08 Warnings Exact identifier application number: M001 Xpect Antacid CALCIUM CARBONATE Cintas Corporation 3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c 2026-01-08 Warnings Exact identifier application number: M001 DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 Floz SODIUM BICARBONATE Evi Labs 47330d09-7db1-254d-e063-6294a90ae7de 2026-01-07 Warnings Exact identifier application number: M001 DE LA CRUZ SODIUM BICARBONATE ANTACID SODIUM BICARBONATE DLC Laboratories, Inc. fc469943-9749-45ee-93f7-90fdbcdc7215 2026-01-07 Warnings Exact identifier application number: M001 De La Cruz Desempacho SODIUM BICARBONATE DLC LABORATORIES, INC. 741e105a-3ed2-4fc7-ab06-273e515a2d16 2026-01-07 Warnings Exact identifier application number: M001 ANTACID AND ANTIGAS CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE Geri-Care Pharmaceuticals, Corp 472eafe8-aa7a-f435-e063-6294a90acf6b 2025-12-30 Warnings Exact identifier application number: M001 ANTACID AND ANTIGAS CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE Geri-Care Pharmaceuticals, Corp 472f5bfc-c676-56da-e063-6294a90a74af 2025-12-30 Warnings Exact identifier application number: M001 ANTACID AND ANTIGAS CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE Geri-Care Pharmaceuticals, Corp 472ffa66-938f-14e7-e063-6394a90ad0ca 2025-12-30 Warnings Exact identifier application number: M001 QC Ultra Strength Antacid Soft Chews, Cherry QC ANTACID SOFT CHEWS, CHERRY Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 26a97517-d3e7-d896-e063-6394a90acc95 2025-12-29 Warnings Exact identifier application number: M001 Tums Chewy Bites CALCIUM CARBONATE Select Consumer Group 3caa037e-3424-f9ce-e063-6294a90ac1e8 2025-12-27 Warnings Exact identifier application number: M001
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-478-48 36800047848 150 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (36800-478-48) 2018-12-15 0000-00-00 No No Current