FDA.reportPublic FDA data

Simethicone

Product NDC
11673-549
11-digit product format
116730549
Labeler code
11673
Product ID
11673-549_56a7c19f-eb0b-c89d-e063-6294a90aca84
Type
HUMAN OTC DRUG
Nonproprietary name
Target Berry Blast Antacid HBG Chew
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Target
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
Substance
DIMETHICONE; CALCIUM CARBONATE
Active strength
80; 750 mg/1; 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], Skin Barrier Activity [PE]
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
Simethicone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE80 mg/1
CALCIUM CARBONATE750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup
H0G9379FGKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1492387Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5245af45-77c7-c95f-e063-6294a90a24f7Available on FDA.report

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 14 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Ultra Stregth AntacidCALCIUM CARBONATEWal-Mart Stores, Inc.cdfe5c95-3f90-4620-a618-18bac0471c3e2025-12-03WarningsExact identifier
application number: M001
Walgreens Fast Acting Heartburn Relief Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.6eae97f3-a174-4cbc-badc-777475d2f7af2025-11-26WarningsExact identifier
application number: M001
Antacid Regular StrengthANTACIDWALGREEN CO.ce5eef7f-497d-4c88-be6a-17eeb6e07f5b2025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACIDWALGREEN CO.2981c5f7-121a-4030-86b1-559061030e7a2025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACID CALCIUM CARBONATEWALGREEN CO.14baa410-6ce3-4ddb-aac7-e2172d1506c42025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACIDWALGREEN CO.aa797e94-6560-41c9-8c71-458a1086e8412025-11-25WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEWALGREEN COMPANYd66ec376-9cac-4de5-aac8-7c6f9aa210ce2025-11-25WarningsExact identifier
application number: M001
Antacid Extra Strength WintergreenANTACIDWALGREEN CO.ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra StrengthANTACIDWALGREEN CO.09ef90c3-1fc3-48be-8071-2fa387a461752025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.6d6cecdc-646b-4c7b-b325-9423c29c57fc2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.e1b55f3a-c6d7-4374-acc7-134786a3765e2025-11-25WarningsExact identifier
application number: M001
ULTRA STRENGTH AntacidCALCIUM CARBONATEWALGREEN COa4dcf7b9-d2c3-45d3-9410-fc4d55052a3c2025-11-25WarningsExact identifier
application number: M001
FAST ACTING Heartburn ReliefALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.48c14005-811a-4868-b33e-9348455048562025-11-25WarningsExact identifier
application number: M001
Walgreens Childrens Saline LaxativeMAGNESIUM HYDROXIDEWALGREEN CO.3813ed22-cf68-4c16-9b61-c398281200792025-11-25WarningsExact identifier
application number: M001
Ultra Strength Assorted BerriesCALCIUM CARBONATESAM'S WEST INCbc619258-7451-460c-9472-95678ea82d6e2025-11-20WarningsExact identifier
application number: M001
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
application number: M001
GERI-MOX ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp03358bc7-8819-4a05-bc13-27fbf486bd262025-11-20WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCd41f0b26-5add-4045-9754-37d70d120d282025-11-20WarningsExact identifier
application number: M001
Tums Chewy Bites Vanilla and MintCALCIUM CARBONATEHaleon US Holdings LLC2b9dd909-c850-3c21-e063-6394a90a15a82025-11-19WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd8fdf4-f762-f936-e053-2a91aa0aa6ee2025-11-19WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11673-549-601167305496060 TABLET, CHEWABLE in 1 BOTTLE (11673-549-60) 2026-07-01NoNoCurrent