Home NDC 0904-6412 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.
DailyMed Product Concepts# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# 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