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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	36800-478		D	Discontinued by firm		2026-10-05
excluded package	package	36800-478	36800-478-47	D	Discontinued by firm		2026-10-05

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bb99b942-1f84-43e1-a18d-3a975cddc59e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-478-47	EA - Each	36800-478	c043ff40-ca37-40eb-b819-e6c80fc8d8ac	1	2012-07-24
36800-478-48	EA - Each	36800-478	31268f09-6a4b-4803-827c-67c95bf401ea	1	2024-04-05

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 7 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra strength gas relief	SIMETHICONE	KROGER COMPANY	ea1c7b4c-91a1-0c1c-e053-2995a90ab823	2026-04-29	Warnings	Exact identifier application number: M001
Calcium Carbonate	CALCIUM CARBONATE	Cardinal Health 107, LLC	8109dd2b-875c-40eb-82ac-d3780bc0c437	2026-04-27	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Bryant Ranch Prepack	77fa8fe5-33ac-44b2-9596-5b276e9f2162	2026-04-24	Warnings	Exact identifier application number: M001
Mylanta All-Family Multi Symptom Stomach Remedy	CALCIUM CARBONATE, SIMETHICONE	Sportpharm LLC	a70f113d-d5a3-44f5-b223-cd1b0e159e1a	2026-04-24	Warnings	Exact identifier application number: M001
Genexa Kids Tummy Relief	CALCIUM CARBONATE	Genexa Inc.	4f9db9dc-6b78-d123-e063-6294a90ae38d	2026-04-16	Warnings	Exact identifier application number: M001
Rugby Extra Strength Antacid	CALCIUM CARBONATE	Rugby Laboratories	c15a5dde-6789-4491-98fd-d248a5c7f076	2026-04-15	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Rugby Laboratories	bd58baac-5790-455a-9c77-236680992579	2026-04-15	Warnings	Exact identifier application number: M001
Rugby Extra Strength Antacid	CALCIUM CARBONATE	Rugby Laboratories	78f11b4b-d203-45c9-9b29-2c135eb66619	2026-04-15	Warnings	Exact identifier application number: M001
Sodium Bicarbonate 10 gr. (650 mg)	SODIUM BICARBONATE	Gendose Pharmaceuticals, LLC	0a0cc46d-372e-4175-932a-065e82d8d353	2026-04-13	Warnings	Exact identifier application number: M001
Extra Strength Antacid Calcium Carbonate, 750mg	CALCIUM CARBONATE CHEWABLE TABLETS	CVS HEALTH CORP	24cdab48-bcc7-e66f-e063-6394a90abbd7	2026-04-11	Warnings	Exact identifier application number: M001
TUMS Smoothies	CALCIUM CARBONATE	Haleon US Holdings LLC	c22944b8-8733-4689-be0c-f320467f79ea	2026-04-01	Warnings	Exact identifier application number: M001
Soothe childrens	CALCIUM CARBONATE	Walgreen Company	0235e083-5f3d-4bae-b14a-b12db623180c	2026-03-31	Warnings	Exact identifier application number: M001
Dulcolax Soft Chews Mixed Berry	MAGNESIUM HYDROXIDE	Chattem, Inc.	fe71907c-b1eb-4433-9337-933a944f3e62	2026-03-31	Warnings	Exact identifier application number: M001
AMAZON ULTRA STRENGTH ANTACID	CALCIUM CARBONATE	AMAZON.COM SERVICES LLC	36cf072c-ab61-47de-8fbc-f1d1d981ec84	2026-03-27	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Bryant Ranch Prepack	f98cac25-63f2-478e-b785-20cba1c56565	2026-03-27	Warnings	Exact identifier application number: M001
Ultra Strength Assorted Fruit Antacid	CALCIUM CARBONATE	Hyvee Inc	44eaa023-0f11-1256-e063-6394a90a4167	2026-03-26	Warnings	Exact identifier application number: M001
Rapidol Sodium Bicarbonate	SODIUM BICARBONATE	Pharmadel LLC	b4c9a653-6f51-7c98-e053-2995a90ada37	2026-03-26	Warnings	Exact identifier application number: M001
Ultra Strength Antacid	CALCIUM CARBONATE	Grocery Outlet, Inc.	4465441f-c518-8c1d-e063-6294a90a7407	2026-03-25	Warnings	Exact identifier application number: M001
Ultra Strength Assorted Berry Antacid	CALCIUM CARBONATE	Hyvee Inc	44ea74ce-2b9f-e578-e063-6394a90ab72d	2026-03-25	Warnings	Exact identifier application number: M001
Antacid Melts	CALCIUM CARBONATE 250MG	Quest Products, LLC	4dcc5323-eafe-0dc8-e063-6294a90acb60	2026-03-24	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308907	calcium carbonate 500 MG (Ca 200 MG) Chewable Tablet	PSN	bb99b942-1f84-43e1-a18d-3a975cddc59e	11
308907	calcium carbonate 500 MG Chewable Tablet	SCD	bb99b942-1f84-43e1-a18d-3a975cddc59e	11
308907	calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable Tablet	SY	bb99b942-1f84-43e1-a18d-3a975cddc59e	11

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Antacid Calcium Drug Facts	Topco Associates LLC.	2025-11-08	HUMAN OTC DRUG LABEL	11