FDA.reportPublic FDA data

Topcare Ultra Strength Antacid Peppermint

Product NDC
76162-131
11-digit product format
761620131
Labeler code
76162
Product ID
76162-131_47a0f780-1d28-4d5c-8344-f29fad84309d
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Topco Associates, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-25
Substance
CALCIUM CARBONATE
Active strength
1000 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
2026-12-31
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
Topcare Ultra Strength Antacid Peppermint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308892Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb434059-7b6e-42e0-acfa-db9879f6a4e4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-131-68Topcare Ultra Strength Antacid Peppermint72 in 1 BOTTLETABLET, CHEWABLE722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-131TOPCARE ULTRA STRENGTH ANTACID PEPPERMINT (CALCIUM CARBONATE) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC]2Current NDC, Legacy NDC, 1 package rows20241213_fb434059-7b6e-42e0-acfa-db9879f6a4e4.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 33 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
application number: M001
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa9654a96-9bfd-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEH E Babfe6688-f852-ba8e-e053-2995a90a49a32023-11-07WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGOODSENSEa9654a96-9bf9-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
ADVANCED ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa964da1d-e1e3-94a8-e053-2a95a90ac8042023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEKROGER COMPANYa1b132d5-00d0-55c1-e053-2a95a90a8d272023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e5fc3f-caf0-84c4-e053-2a95a90af6552023-11-07WarningsExact identifier
application number: M001
ANTACID PLUSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS LLCb8e233c7-eaa0-b1ec-e053-2a95a90a05492023-11-07WarningsExact identifier
application number: M001
Antacid PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS, LLCb93191e8-28a7-6c8f-e053-2995a90ac3272023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ADVANCED ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEDOLGENCORP, LLCb6993a5a-6144-ba65-e053-2995a90aee9b2023-11-07WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONb4656a2f-a866-5f7a-e053-2995a90ac2c22023-11-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association9f410b3a-5579-4fae-84b1-5cd35563451e2023-11-06WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association60de23d0-6e75-3b97-e053-2a91aa0aea5e2023-11-06WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEMAJOR Pharmaceuticals Inc.536b143d-a1d7-4972-a90b-248e419370702023-11-02WarningsExact identifier
application number: M001
ALMACONE DOUBLE STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIES25f22cff-2864-4853-a7f8-8edd9f8f3c292023-11-02WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e8215a4-0136-bfdd-e053-2991aa0a5ddf2023-11-01WarningsExact identifier
application number: M001
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e946ed2-819e-fb40-e053-2991aa0a6f772023-11-01WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSNfb434059-7b6e-42e0-acfa-db9879f6a4e42
308892calcium carbonate 1000 MG Chewable TabletSCDfb434059-7b6e-42e0-acfa-db9879f6a4e42
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSYfb434059-7b6e-42e0-acfa-db9879f6a4e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76162-131-687616201316872 TABLET, CHEWABLE in 1 BOTTLE (76162-131-68) 2022-04-250000-00-00NoNoCurrent