FDA.reportPublic FDA data

Pepto

Product NDC
58933-446
11-digit product format
589330446
Labeler code
58933
Product ID
58933-446_5d1b76a3-07d2-f0d3-e063-6394a90a7046
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-20
Substance
CALCIUM CARBONATE
Active strength
400 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
Pepto
Brand name suffix
Kids
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE400 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-06-10Pepto ®  Kids Chewable Tablets
2021-06-10Pepto ®  Kids Chewable Tablets
2021-01-29Pepto ®  Kids Chewable Tablets
2021-01-29Pepto ®  Kids Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-446-24PeptoKids24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE249
58933-446-24PeptoKids1 in 1 CARTONTABLET, CHEWABLE19
58933-446-72PeptoKids3 in 1 CELLO PACKTABLET, CHEWABLE39
58933-446-72PeptoKids1 in 1 CARTONTABLET, CHEWABLE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-446PEPTO KIDS (CALCIUM CARBONATE) TABLET, CHEWABLE [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]8Current NDC, Legacy NDC, 4 package rows20241012_673c45dc-84fd-5b45-e053-2a91aa0adea8.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 32 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Milk of MagnesiaMAGNESIUM HYDROXIDEPharmacy Value Alliance, LLCc3cdaa2b-db34-872d-e053-2995a90a38262023-12-20WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
application number: M001
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
application number: M001
Humco Milk of MagnesiaMAGNESIUM HYDROXIDEHumco Holding Group, Inc.b6c90fb4-2673-7e29-e053-2995a90ae9e12023-12-15WarningsExact identifier
application number: M001
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
application number: M001
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
application number: M001
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONESato Pharmaceutical Co., Ltd.0af4355f-e160-409d-8471-2de98dbc6f7c2023-11-10WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
application number: M001
GERI-LANTA SUPREME CHERRYCALCIUM CARBONATE, MAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp7fbc654b-a0d4-408c-bb5a-eb50b7b543822023-11-08WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317865calcium carbonate 400 MG (Ca 170 MG) Chewable TabletPSN673c45dc-84fd-5b45-e053-2a91aa0adea89
701392Pepto-Bismol Children's 400 MG (Ca 161 MG) Chewable TabletPSN673c45dc-84fd-5b45-e053-2a91aa0adea89
701392calcium carbonate 400 MG Chewable Tablet [Pepto-Bismol Children's]SBD673c45dc-84fd-5b45-e053-2a91aa0adea89
317865calcium carbonate 400 MG Chewable TabletSCD673c45dc-84fd-5b45-e053-2a91aa0adea89
317865calcium carbonate 400 MG (as calcium 161 MG) Chewable TabletSY673c45dc-84fd-5b45-e053-2a91aa0adea89
701392Pepto-Bismol Children's 400 MG (calcium 161 MG) Chewable TabletSY673c45dc-84fd-5b45-e053-2a91aa0adea89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-446-24589330446241 BOTTLE, PLASTIC in 1 CARTON (58933-446-24) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2018-01-210000-00-00NoNoCurrent
58933-446-72589330446723 CARTON in 1 CELLO PACK (58933-446-72) / 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC3 carton2018-01-21NoNoCurrent