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 29 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	RITE AID CORPORATION	9889cf9e-3f6a-4abc-b723-0b295c7c8f93	2024-10-30	Warnings	Exact identifier application number: M001
Rite Aid Pharmacy Extra Strength Assorted Berries	CALCIUM CARBONATE	RITE AID CORPORATION	f697de02-7df9-4419-9835-8b65bbaf4215	2024-10-29	Warnings	Exact identifier application number: M001
Premier Value Smooth Antacid Extra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	0de2c4c5-46fb-4081-aa96-b36794e3983f	2024-10-28	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Extra Strength Tropical Fruit	ANTACID TABLETS	Chain Drug Consortium	8999b9c1-05d0-496b-88f2-062908a4fadc	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Extra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	ef8ab31b-d050-446a-bca9-4a94d4ba1752	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Extra Strength Original Flavor	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	PHARMACY VALUE ALLIANCE, LLC	e33db45a-594e-4af8-ab16-10010fc8a388	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Extra Strength Freshmint Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE	CHAIN DRUG CONSORTIUM, LLC	1192ebeb-f6cc-45db-8f07-12d36eb55a5f	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Maximum Strength Assorted Fruit	CALCIUM CARBONATE, SIMETHICONE	PHARMACY VALUE ALLIANCE, LLC	e25bf9ca-415b-4a3e-a502-59074308da54	2024-10-25	Warnings	Exact identifier application number: M001
PV Extra Strength Antacid	CALCIUM CARBONATE	PHARMACY VALUE ALLIANCE, LLC	8c92de83-ed60-46c3-b289-4b45a1915e24	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Ultra Strength Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium	26c742a7-5806-44e0-bef0-c70a9d77dd23	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Chewable Antacid Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium, LLC	00a58373-77ab-4a46-9862-d179e17c731a	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Multi Symptom Antacid Berry Flavor	CALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONE	Pharmacy Value Alliance LLC	69e0c4a8-04ae-461b-bf47-4180bccd91d6	2024-10-25	Warnings	Exact identifier application number: M001
Premier Value Regular Strength Chewable Antacid Peppermint Assorted Fruit	ANTACID TABLETS	Chain Drug Consortium, LLC	245e195f-fd67-497b-83d4-fef75cea8b5b	2024-10-25	Warnings	Exact identifier application number: M001
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	53380470-5748-6fa7-548e-7484ef204c0f	2024-10-21	Warnings	Exact identifier application number: M001
OHTAS ISAN ANTACID	CALCIUM CARBONATE, SODIUM BICARBONATE	OHTA'S ISAN CO.,LTD.	8723fe90-8402-4511-b6c6-b71cf98513e3	2024-10-21	Warnings	Exact identifier application number: M001
Citrus Flavored Antacid	CALCIUM CARBONATE	JHK DBA American Safety & First Aid	79f2b495-a438-408e-9572-b6c3516db52c	2024-10-15	Warnings	Exact identifier application number: M001
NUTRALOX	CALCIUM CARBONATE	A-S Medication Solutions	524e26a9-c69f-4e25-b83d-f4c65adca83d	2024-10-11	Warnings	Exact identifier application number: M001
Mag-AL Liquid	ALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDE	PAI Holdings, LLC	b1f2d137-f5f7-4800-a1df-ef5d25544bc9	2024-10-08	Warnings	Exact identifier application number: M001
Melox	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Belmora LLC	bfc78d44-dc90-4f69-85af-a23dd70c68d2	2024-10-04	Warnings	Exact identifier application number: M001
HEB Extra Strength sugar free Antacid 174	CALCIUM CARBONATE	H E B	17cd3717-2fc3-1693-e063-6394a90ae03d	2024-09-17	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