FDA.reportPublic FDA data

Humco Dewees Carminative

Product NDC
0395-0713
11-digit product format
003950713
Labeler code
0395
Product ID
0395-0713_0c92d0b3-1768-de2d-e063-6394a90a34d1
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium Carbonate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Humco Holding Group, inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
MAGNESIUM CARBONATE
Active strength
50 mg/mL
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
Humco Dewees Carminative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM CARBONATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0E53J927NAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205337Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
163bceeb-ca74-413e-88b9-5c7bc9bbeb0dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0713-92Humco Dewees Carminative59 mL in 1 BOTTLE, PLASTICSUSPENSION596

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0713-92ML - Milliliter0395-0713a604230f-3c0a-491a-bf5f-b77018a8986212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NAHUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DHUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
ASAFETIDAINACTIVE INGREDIENTW9FZA51AS1HUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554HUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0713HUMCO DEWEES CARMINATIVE (MAGNESIUM CARBONATE) SUSPENSION [HUMCO HOLDING GROUP, INC.]6Current NDC, Legacy NDC, 1 package rows20231216_163bceeb-ca74-413e-88b9-5c7bc9bbeb0d.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 31 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS CHEWY BITESCALCIUM CARBONATE TABLET, CHEWABLELil' Drug Store Products, Inc.f67bd767-e9f1-2377-e053-2a95a90a0a2d2024-03-29WarningsExact identifier
application number: M001
Childrens Robitussin Cough and Cold CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCfcd0a8e0-ac2a-039a-be3c-534195d6bcfd2024-03-17WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC35f79dcf-1743-4d9f-aba5-5ead6b0563092024-03-15WarningsExact identifier
application number: M001
TUMS extra strength, smoothiesCALCIUM CARBONATEHaleon US Holdings LLC11078d7c-373b-4c7b-b33b-f1deba613fc12024-03-14WarningsExact identifier
application number: M001
Tums Chewy Bites Tropical Fruit SmoothieCALCIUM CARBONATEHaleon US Holdings LLC500f821e-dd27-4c7c-b629-a826b2e57c132024-03-11WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC3988e3f8-b276-43a0-bdd3-01ddd422c9862024-03-03WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLC9e54f687-4072-42fd-a14b-af67fe8b6cc42024-03-03WarningsExact identifier
application number: M001
Tums Regular StrengthCALCIUM CARBONATEHaleon US Holdings LLCac80f627-3f51-425b-8c75-e07363048b002024-03-03WarningsExact identifier
application number: M001
Tums Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC5090f60f-fa98-470b-bafd-bb64e6b28fcc2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
application number: M001
Tums Chewy Bites Berry ShakeCALCIUM CARBONATEHaleon US Holdings LLC9043983c-7ee4-4971-8885-36f814bb570f2024-03-02WarningsExact identifier
application number: M001
Tums Chewy DelightsCALCIUM CARBONATEHaleon US Holdings LLC189850d0-6f06-45bd-bd7e-9063ee580d0b2024-03-02WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
application number: M001
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
application number: M001
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
application number: M001
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
application number: M001
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205337magnesium carbonate 250 MG in 5 mL Oral SuspensionPSN163bceeb-ca74-413e-88b9-5c7bc9bbeb0d6
205337magnesium carbonate 50 MG/ML Oral SuspensionSCD163bceeb-ca74-413e-88b9-5c7bc9bbeb0d6
205337magnesium carbonate 250 MG per 5 ML Oral SuspensionSY163bceeb-ca74-413e-88b9-5c7bc9bbeb0d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0713-920039507139259 mL in 1 BOTTLE, PLASTIC (0395-0713-92) 59 ml2017-11-130000-00-00NoNoCurrent