Topcare antacid calcium

Product NDC: 36800-962
11-digit product format: 368000962
Labeler code: 36800
Product ID: 36800-962_4311dc53-df6c-63b4-e063-6394a90a6615
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: 1000 mg/1
Pharmacologic classes: Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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	36800-962		D	Discontinued by firm		2026-10-12
excluded package	package	36800-962	36800-962-23	D	Discontinued by firm		2026-10-12

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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	36800-962-23	`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	1000 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
308892	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
ad001c7f-cd3f-4577-a793-50055e432747	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
36800-962-25	Topcare antacid calcium	72 in 1 BOTTLE	TABLET, CHEWABLE	72		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-962	TOPCARE ANTACID CALCIUM (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC]	9	Current NDC, Legacy NDC, 1 package rows	20241107_ad001c7f-cd3f-4577-a793-50055e432747.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 15 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPREME ANTACID	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	FAMILY DOLLAR SERVICES INC	5e996df3-25a4-b259-e053-2a91aa0a4311	2025-11-19	Warnings	Exact identifier application number: M001
GERI-LANTA ANTACID ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	a7d7298f-44d6-4e09-8578-7fe311243002	2025-11-19	Warnings	Exact identifier application number: M001
GERI-MOX MAX CHERRY	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Geri-Care Pharmaceuticals, Corp	8e57bcf5-2960-4c41-8bf2-83cb1ee50168	2025-11-19	Warnings	Exact identifier application number: M001
Tums Antacid Chewy Bites	CALCIUM CARBONATE 750 MG	R J General Corporation	6208d11d-0670-4a20-a3fc-ebc764a8e6cd	2025-11-17	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID/ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	RUGBY LABORATORIES	b244fce9-9626-e947-e053-2995a90ab8f9	2025-11-17	Warnings	Exact identifier application number: M001
Antacid Childrens	CALCIUM CARBONATE	CVS Pharmacy	08953df1-cc29-452f-bc69-b19970a1fd2e	2025-11-15	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Marlex Pharmaceuticals Inc	0bb322a5-fb92-14de-e063-6294a90a4c1b	2025-11-14	Warnings	Exact identifier application number: M001
magnesium oxide	MAGNESIUM OXIDE	Marlex Pharmaceuticals Inc.	dc57893c-068a-37d8-e053-2a95a90aa054	2025-11-14	Warnings	Exact identifier application number: M001
Earthmed Soothe Chewable Orange	CITRIC ACID	Earthmed LLC	439543fe-ceb9-4c5c-e063-6294a90a9b70	2025-11-14	Warnings	Exact identifier application number: M001
MAXIMUM STRENGTH ANTACID MINT	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	CVS	3ce054f3-2953-5f7d-e054-00144ff8d46c	2025-11-11	Warnings	Exact identifier application number: M001
Topcare Antacid Extra Strength Assorted Berry	CALCIUM CARBONATE	Topco Associates LLC	14f6f475-32d6-4783-8dcc-1fe265902d55	2025-11-10	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC	38c26f49-fb5e-480c-9164-bf5edcf0726b	2025-11-10	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC.	bb99b942-1f84-43e1-a18d-3a975cddc59e	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium Regular Strength	CALCIUM CARBONATE	Topco Associates LLC	2606ac08-9760-4ff6-8d90-51fbb04e6ac8	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium Extra Strength	CALCIUM CARBONATE	Topco Associates LLC	495d97b0-d95c-46d1-a76a-56ac7f823538	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium Extra Strength	CALCIUM CARBONATE	Topco Associates LLC.	73b4cda2-900a-4380-a0ae-0abfecdb7263	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Extra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	Topco Associates LLC	2677ca2b-b211-475e-a9c4-643fd54a744f	2025-11-08	Warnings	Exact identifier application number: M001
TopCare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC	b94eac38-62d0-49a2-bb49-053fda8129e2	2025-11-08	Warnings	Exact identifier application number: M001
Topcare Antacid Calcium	CALCIUM CARBONATE	Topco Associates LLC	04b3d397-df99-44e2-a191-6e9199b08398	2025-11-08	Warnings	Exact identifier application number: M001
topcare Antacid Calcium Ultra Strength	CALCIUM CARBONATE	Topco Associates LLC	6e2788b3-1e33-4908-aa2c-475d69b94ee6	2025-11-08	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
308892	calcium carbonate 1000 MG (Ca 400 MG) Chewable Tablet	PSN	ad001c7f-cd3f-4577-a793-50055e432747	10
308892	calcium carbonate 1000 MG Chewable Tablet	SCD	ad001c7f-cd3f-4577-a793-50055e432747	10
308892	calcium carbonate 1000 MG (calcium 400 MG) Chewable Tablet	SY	ad001c7f-cd3f-4577-a793-50055e432747	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-962-23	36800096223	72 TABLET, CHEWABLE in 1 BOTTLE (36800-962-23)	2016-03-03	0000-00-00	No	No	Current
36800-962-25	36800096225	72 TABLET, CHEWABLE in 1 BOTTLE (36800-962-25)	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	10
Topco Associates LLC. Antacid Calcium Drug Facts	Topco Associates LLC	2018-06-27	HUMAN OTC DRUG LABEL	2