Major Regular Strength

Product NDC: 0904-6412
11-digit product format: 009046412
Labeler code: 0904
Product ID: 0904-6412_3c2b7210-3921-4645-8dcc-9d63b149a8fd
Type: HUMAN OTC DRUG
Nonproprietary name: Antacid Tablets
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M001
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-08-12
Substance: CALCIUM CARBONATE
Active strength: 500 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: 2027-12-31
Current FDA listing: Yes

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: Major Regular Strength
Brand name suffix: Assorted Flavors
Listing expiration: 2027-12-31

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
2ba0eeb2-7048-4259-83d5-9f4ec1c92d32	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
0904-6412-92	Major Regular StrengthAssorted Flavors	150 in 1 BOTTLE, PLASTIC	TABLET, CHEWABLE	150		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6412-92	EA - Each	0904-6412	bb975321-582f-4b0a-b5a6-7010bc851aaa	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
ADIPIC ACID	INACTIVE INGREDIENT	76A0JE0FKJ	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6412	MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 1 package rows	20241024_2ba0eeb2-7048-4259-83d5-9f4ec1c92d32.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 26 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regular Strength Antacid Mint	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Topco Associates, LLC	59c16c09-c23d-4a37-8460-d6c00a268ed5	2024-12-26	Warnings	Exact identifier application number: M001
ANTACID	CALCIUM CARBONATE	Advance Pharmaceutical Inc.	face4e8c-3d0f-4c2e-83c1-44397b225ae7	2024-12-26	Warnings	Exact identifier application number: M001
ANTACID	CALCIUM CARBONATE	Advance Pharmaceutical Inc.	3203dfc5-2cb1-4703-8d81-63fba07ddd98	2024-12-26	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Richmond Pharmaceuticals, Inc.	9119b7f0-3e8a-7be7-e053-2995a90a4634	2024-12-26	Warnings	Exact identifier application number: M001
Magnesium Oxide	MAGNESIUM OXIDE	Richmond Pharmaceuticals, Inc.	db5941b2-0a04-452a-8fbc-bd5e40fadfb1	2024-12-26	Warnings	Exact identifier application number: M001
HEB Extra Strength Smooth Antacid Assorted Fruits	CALCIUM CARBONATE	H E B	2faac316-7b59-4df8-b751-37069e865263	2024-12-26	Warnings	Exact identifier application number: M001
Good Neighbor Pharmacy Antacid Extra Strength	CALCIUM CARBONATE	AmerisourceBergen Drug Corporation	5e3a3c20-dabe-4427-9e75-99759905caa0	2024-12-26	Warnings	Exact identifier application number: M001
Maximum Strength Antacid Cherry liquid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Topco Associates, LLC	31d2e77d-5eda-4f47-917c-3390d6c782af	2024-12-26	Warnings	Exact identifier application number: M001
Maximum Strength Antacid Mint	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Topco Associates, LLC	50ceff1e-b6df-40f8-89f3-667cc8f9e750	2024-12-26	Warnings	Exact identifier application number: M001
HEB Extra Strength Smooth Antacid Peppermint	CALCIUM CARBONATE	H E B	d04e691e-6d1c-4c39-9504-7ac0f1bd197d	2024-12-26	Warnings	Exact identifier application number: M001
Antacid	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	H E B	f294cf44-fb21-4b2e-8b7c-efd41416c6b2	2024-12-26	Warnings	Exact identifier application number: M001
Antacid	CALCIUM CARBONATE	Trifecta Pharmaceuticals USA LLC	14a7916e-5363-7f1b-e063-6294a90a20aa	2024-12-20	Warnings	Exact identifier application number: M001
maximum strength antacid cherry	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	UNITED NATURAL FOODS, INC. DBA UNFI	d6b49f0a-cf05-4b1b-8cad-c5795aa31645	2024-12-20	Warnings	Exact identifier application number: M001
GOODSENSE Ultra Strength Antacid Peppermint	CALCIUM CARBONATE	GoodSense	04950b56-7760-4b6c-8110-86b6a3f795b4	2024-12-19	Warnings	Exact identifier application number: M001
Goodsense Regular Strength Antacid Peppermint	CALCIUM CARBONATE	GoodSense	32c04f3e-59f3-44aa-ad92-672444982710	2024-12-19	Warnings	Exact identifier application number: M001
GOODSENSE Ultra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	GoodSense	ad4d51f6-b55b-45db-b034-fb3da54fbe99	2024-12-19	Warnings	Exact identifier application number: M001
TUMS Extra Strength Sugar-Free	CALCIUM CARBONATE	Haleon US Holdings LLC	3495102f-55d2-4a94-8d55-f46f49e00c27	2024-12-19	Warnings	Exact identifier application number: M001
Goodsense Extra Strength Antacid Assorted Fruit	CALCIUM CARBONATE	GoodSense	ae6270fc-0f8d-4bba-8f12-adba3f07f7c5	2024-12-19	Warnings	Exact identifier application number: M001
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry Antacid	CALCIUM CARBONATE	Chain Drug Marketing Association Inc.	ec729051-72d3-4d1a-8e39-d4495d5c1cf3	2024-12-18	Warnings	Exact identifier application number: M001
Guardian Extra Strength Antacid	CALCIUM CARBONATE	Guardian Drug Company	aef3d830-c5c3-4f72-86ba-d31945a756db	2024-12-18	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	2ba0eeb2-7048-4259-83d5-9f4ec1c92d32	10
308907	calcium carbonate 500 MG Chewable Tablet	SCD	2ba0eeb2-7048-4259-83d5-9f4ec1c92d32	10
308907	calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable Tablet	SY	2ba0eeb2-7048-4259-83d5-9f4ec1c92d32	10
308907	calcium carbonate 500 MG (Ca 200 MG) Chewable Tablet	PSN	af10dfb6-fef3-3410-e053-2995a90a9130	3
308907	calcium carbonate 500 MG Chewable Tablet	SCD	af10dfb6-fef3-3410-e053-2995a90a9130	3
308907	calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable Tablet	SY	af10dfb6-fef3-3410-e053-2995a90a9130	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6412-92	00904641292	150 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0904-6412-92)	2014-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Regular Strength Antacid 150 Chewable Tablets	Major Pharmaceuticals	2026-07-13	HUMAN OTC DRUG LABEL	11
Major Regular Strength Antacid 150 Chewable Tablets	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN OTC DRUG LABEL	3
Major Regular Strength Antacid 150 Chewable Tablets	REMEDYREPACK INC.	2022-06-16	HUMAN OTC DRUG LABEL	8