Titralac Plus

Product NDC: 55298-013
11-digit product format: 552980013
Labeler code: 55298
Product ID: 55298-013_8e9a93d6-f0ff-4ea5-bed9-688ab924aa85
Type: HUMAN OTC DRUG
Nonproprietary name: Calcium Carbonate, Dimethicone
Dosage form: TABLET
Route: ORAL
Labeler: iNova Pharmaceuticals Pty, Ltd
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-01-01
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE; DIMETHICONE
Active strength: 420 mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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	55298-013		I	Inactivated by FDA		2026-10-05
excluded package	package	55298-013	55298-013-10	I	Inactivated by FDA		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 · 44 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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`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	55298-013-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55298-013-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55298-013-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55298-013-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55298-013-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55298-013-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55298-013-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55298-013-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55298-013-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55298-013-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55298-013-10	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55298-013-10	2019-10-29	C162847	48780-1	960f7f55-c56f-8e05-e053-dbdaa90a074a	68725b83-46fc-47ae-bb5c-51f080dcacfe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55298-013-10	Titralac Plus	100 in 1 BOTTLE, PLASTIC	TABLET	100		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Calcium Carbonate	ACTIVE INGREDIENT	H0G9379FGK	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
Calcium	ACTIVE MOIETY	SY7Q814VUP	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
dimethicone	ACTIVE MOIETY	92RU3N3Y1O	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
glycine	INACTIVE INGREDIENT	TE7660XO1C	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
saccharin	INACTIVE INGREDIENT	FST467XS7D	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
spearmint oil	INACTIVE INGREDIENT	C3M81465G5	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55298-013	TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]	1	Legacy NDC, 1 package rows	20110428_68725b83-46fc-47ae-bb5c-51f080dcacfe.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237867	calcium carbonate 420 MG (Ca 168) / simethicone 21 MG Chewable Tablet	PSN	68725b83-46fc-47ae-bb5c-51f080dcacfe	1
701678	calcium carbonate 420 MG / simethicone 21 MG Chewable Tablet [Titralac Plus]	SBD	68725b83-46fc-47ae-bb5c-51f080dcacfe	1
237867	calcium carbonate 420 MG / simethicone 21 MG Chewable Tablet	SCD	68725b83-46fc-47ae-bb5c-51f080dcacfe	1
701678	Titralac Plus (calcium carbonate 420 MG / simethicone 21 MG) Chewable Tablet	SY	68725b83-46fc-47ae-bb5c-51f080dcacfe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55298-013-10	55298001310	100 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Titralac Plus - iNova Pharmaceuticals Pty, Ltd	iNova Pharmaceuticals Pty, Ltd	2011-05-01	HUMAN OTC DRUG LABEL	1