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 2 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Extra Strength Sugar Free	CALCIUM CARBONATE	KROGER COMPANY	3f737ce2-961e-4bd0-ae6d-078248cf1c67	2026-08-31	Warnings	Exact identifier application number: M001
Kroger Extra Strength Assorted Berry	CALCIUM CARBONATE	KROGER COMPANY	fa191237-d230-4528-8dff-50e8d5c65b6d	2026-08-31	Warnings	Exact identifier application number: M001
Kroger Ultra Strength Assorted Berry	CALCIUM CARBONATE	KROGER COMPANY	b7db77a7-0580-455b-a2ef-a68584f03981	2026-08-31	Warnings	Exact identifier application number: M001
Ultra Strength Natural Antacid	CALCIUM CARBONATE	KROGER COMPANY	2931d427-b2be-4db9-a58d-ff89c221ff51	2026-08-31	Warnings	Exact identifier application number: M001
Ultra Strength Antacid	ANTACID TABLETS	THE KROGER CO.,	f5d82d1b-2f75-4af4-8337-a5bd28c26fb7	2026-08-31	Warnings	Exact identifier application number: M001
Kroger Extra Strength Assorted Fruit	CALCIUM CARBONATE	KROGER COMPANY	486d7a5f-cbc8-4f86-b12e-c5325bd8c62d	2026-08-31	Warnings	Exact identifier application number: M001
GERI-LANTA MAXIMUM STRENGTH	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Preferred Pharmaceuticals Inc.	3b049027-30ac-4c78-a4f1-8191f7ed45bf	2026-08-27	Warnings	Exact identifier application number: M001
Extra Strength Gas Relief	SIMETHICONE	Shield Pharmaceuticals Corp	534144be-fcaf-400d-b772-595c62ae6ea6	2026-08-27	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Guardian Drug Company	48ec50ab-f24b-367b-e063-6294a90ad736	2026-08-27	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	KROGER COMPANY	b9e61a03-e008-50ab-e053-2a95a90a3210	2026-08-26	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	CVS PHARMACY	af71e02d-e7c7-f925-e053-2995a90a0861	2026-08-26	Warnings	Exact identifier application number: M001
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M001
Dr. Sana Lemon Alivio Digestivo UPSET STOMACH	EFFERVESCENT ANTACID	EVI LABS	59cdf417-e5c0-6bb2-e063-6294a90a9c51	2026-08-24	Warnings	Exact identifier application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACH	EFFERVESCENT ANTACID	EVI LABS	59d07c2d-ef11-bd32-e063-6394a90af87d	2026-08-24	Warnings	Exact identifier application number: M001
Genexa Antacid Maximum Strength	CALCIUM CARBONATE	Genexa Inc.	3a39d91c-2dcd-71d6-e063-6394a90a5474	2026-08-22	Warnings	Exact identifier application number: M001
Mag-AL Plus	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	PAI Holdings, LLC dba PAI Pharma	896ab07a-1b40-43ab-8589-3be86b1c4198	2026-08-19	Warnings	Exact identifier application number: M001
CVS Health Extra Strength Antacid	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	CVS PHARMACY	8629529e-4363-4d37-9ae0-27193868df32	2026-08-19	Warnings	Exact identifier application number: M001
Mylanta Fall Harvest Collection Spiced Apple Cider	CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	5a6040ff-1779-3215-e063-6294a90aaab1	2026-08-15	Warnings	Exact identifier application number: M001
Mylanta Fall Harvest Collection Pumpkin Spice	CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE	Infirst Healthcare Inc.	5a60a221-5b37-806e-e063-6394a90a5ccc	2026-08-15	Warnings	Exact identifier application number: M001
CVS Naturals	CALCIUM CARBONATE	CVS PHARMACY	899f057a-914d-49ca-a9fd-9fc48149782a	2026-08-14	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