Home NDC 36800-485 Topcare Antacid Calcium
Product NDC 36800-485
11-digit product format 368000485
Labeler code 36800
Product ID 36800-485_431167cc-d6fd-89d9-e063-6294a90a9b51
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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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 36800-485-47 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
Brand name suffix Regular Strength
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 36800-485-48 Topcare Antacid CalciumRegular Strength 150 in 1 BOTTLE TABLET, CHEWABLE 150 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIUM CARBONATE ACTIVE INGREDIENT H0G9379FGK TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 CARBONATE ION ACTIVE MOIETY 7UJQ5OPE7D TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-485 TOPCARE ANTACID CALCIUM REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC] 10 Current NDC, Legacy NDC, 1 package rows 20241107_2606ac08-9760-4ff6-8d90-51fbb04e6ac8.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 25 of 34 · 678 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcium Carbonate 1250 mg CALCIUM CARBONATE CitraGen Pharmaceuticals, Inc. 766b3f3f-8bd1-281c-e053-2991aa0af54b 2025-01-30 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) CALCIUM CARBONATE CitraGen Pharmaceuticals, Inc. 723b940d-4f4b-f2e6-e053-2991aa0a8bcc 2025-01-30 Warnings Exact identifier application number: M001 Ultra Strength Antacid CALCIUM CARBONATE CVS 2bc4c71c-a9c5-17df-e063-6294a90ac88c 2025-01-27 Warnings Exact identifier application number: M001 Goodsense Ultra Strength Antacid CALCIUM CARBONATE Good Sense (Geiss, Destin & Dunn, Inc.) 492deace-7ea1-4fe3-a4c7-b2c6f195d68c 2025-01-20 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) (Antacid) CALCIUM CARBONATE 10GR (648 MG) Ulai Health LLC 641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a 2025-01-20 Warnings Exact identifier application number: M001 GoodSense Extra Strength Antacid CALCIUM CARBONATE GoodSense 2fcdeb06-17de-49d8-97bb-8d31e1c0c61f 2025-01-20 Warnings Exact identifier application number: M001 HEB Extra Stregth Antacid CALCIUM CARBONATE H E B dcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e48 2025-01-20 Warnings Exact identifier application number: M001 Aluminum Hydroxide, Magnesium Hydroxide and Simethicone ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE Everpharm LLC 2bda74cb-e77d-46bb-e063-6394a90af580 2025-01-16 Warnings Exact identifier application number: M001 Childrens Antacid CALCIUM CARBONATE CVS 1bf90c0c-b639-1c06-e063-6394a90ab85b 2025-01-16 Warnings Exact identifier application number: M001 Sodium Bicarbonate SODIUM BICARBONATE World Perfumes Inc a83544e4-ec09-1e95-e053-2995a90ab7b9 2025-01-15 Warnings Exact identifier application number: M001 Sodium Bicarbonate 10 gr SODIUM BICARBONATE Reliable 1 Laboratories LLC 321a772c-c44c-3d4e-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M001 Calcium Carbonate 500 mg CALCIUM CARBONATE Reliable 1 Laboratories LLC 322f1b54-abe9-11a7-e054-00144ff8d46c 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a27a71-b7b2-12aa-e063-6294a90a312f 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a7720f-1e74-7578-e063-6394a90a5eae 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a78060-7f0d-c4bd-e063-6294a90ae152 2025-01-15 Warnings Exact identifier application number: M001 Soothe Chewable CITRIC ACID Carolina Cannabis Creations LLC 04a78a5c-e3b5-f362-e063-6394a90a0807 2025-01-15 Warnings Exact identifier application number: M001 Rolaids Extra Strength Mint CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE Chattem, Inc. 604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e 2025-01-15 Warnings Exact identifier application number: M001 Extra Strength Smooth Antacid CALCIUM CARBONATE H E B 19a3221f-e0c1-c47a-e063-6394a90a1f01 2025-01-14 Warnings Exact identifier application number: M001 Childrens Stomach Relief Antacid CALCIUM CARBONATE H E B 18fae1aa-1001-8035-e063-6394a90adc66 2025-01-14 Warnings Exact identifier application number: M001 Calcium Carbonate 10 gr (648 mg) (Antacid) CALCIUM CARBONATE 10GR (648 MG) Aphena Pharma Solutions - Tennessee, LLC ac839363-94fd-4c60-b5b6-70e4488ce1dd 2025-01-09 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 36800-485-48 36800048548 150 TABLET, CHEWABLE in 1 BOTTLE (36800-485-48) 2018-12-15 0000-00-00 No No Current