FDA.reportPublic FDA data

Tumeez Organic Apple

Product NDC
72427-2000
11-digit product format
724272000
Labeler code
72427
Product ID
72427-2000_59e3f013-4da4-88cc-e063-6294a90ab5cf
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
LOZENGE
Route
ORAL
Labeler
BFY LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-21
Substance
CALCIUM CARBONATE
Active strength
200 mg/7g
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
Tumeez Organic Apple
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE200 mg/7g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89NA02M4RXInternal UNII lookup
H0G9379FGKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2204565Internal RxNorm lookup
2667489Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f561685a-5260-59c6-e053-2a95a90ae206Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72427-2000-0Tumeez Organic Apple7140 g in 1 BOXLOZENGE714011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72427-2000LOLLEEZ VARIETY PACK (PECTIN) LOZENGE LOLLEEZ BIRTHDAY CAKE - CONVENTIONAL (PECTIN) LOZENGE LOLLEEZ BIRTHDAY CAKE (PECTIN) LOZENGE LOLLEEZ ORANGE MANGO (PECTIN) LOZENGE LOLLEEZ MIXED BERRY (PECTIN) LOZENGE TUMEEZ VARIETY PACK (CALCIUM CARBONATE) LOZENGE LOLLEEZ STRAWBERRY (PECTIN) LOZENGE LOLLEEZ WATERMELON (PECTIN) LOZENGE SOOTHEEZ STRAWBERRY LEMONADE (PECTIN) LOZENGE TUMEEZ ORGANIC GRAPE (CALCIUM CARBONATE) LOZENGE SOOTHEEZ BERRY LEMONADE (PECTIN) LOZENGE SOOTHEEZ BIRTHDAY CAKE (PECTIN) LOZENGE SOOTHEEZ WATERMELON MINT (PECTIN) LOZENGE TUMEEZ ORGANIC APPLE (CALCIUM CARBONATE) LOZENGE [BFY LLC]10Current NDC, 1 package rows20250509_f561685a-5260-59c6-e053-2a95a90ae206.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 20 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Ultra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADEReab5a905-67fb-494e-8f55-aeeab4c2dce22025-08-22WarningsExact identifier
application number: M001
Leader Extra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER81911f6d-7edf-4183-9720-2f20a5db498d2025-08-21WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEBJWC (Berkley & Jensen / BJ's)2f32dde8-502e-eefa-e063-6294a90abf202025-08-19WarningsExact identifier
application number: M001
CVS Health Ultra Strength Natural Antacid Peppermint FlavorANTACID TABLETSCVS Pharmacy,Inc.4f18fd8d-4d6a-4b1d-8a94-b64592f73ad02025-08-13WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.b84d80c6-0240-4276-8e47-74a918f3d86a2025-08-12WarningsExact identifier
application number: M001
AntacidCALCIUM CARBONATEProStat First Aid3bb49eb3-2eaa-af8d-e063-6294a90a40352025-08-06WarningsExact identifier
application number: M001
Maximum Strength Antacid and AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEMeijer, Inc.30a0455d-63e0-95cc-e063-6394a90ada6b2025-07-30WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEMenper Distributors Inc.6efb4da0-03ae-4df6-acd7-e8023d20d4b32025-07-22WarningsExact identifier
application number: M001
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd9234e-d1cc-4cce-e053-2991aa0a457e2025-07-09WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWestminster Pharmaceuticals, LLC9dcfc778-5fd6-4c68-8d37-a5385e3746172025-07-08WarningsExact identifier
application number: M001
MGC Health Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3958ec0a-8f32-6918-e063-6294a90ac1c42025-07-07WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEMajor Pharmaceuticals1bc90fa7-fcce-4a9b-862f-f30ab602ecab2025-07-07WarningsExact identifier
application number: M001
KOSHER MEDS antacidCALCIUM CARBONATEMollec Inc7783d6a2-56e3-4542-ad1d-60680e03532b2025-07-01WarningsExact identifier
application number: M001
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
application number: M001
Gaviscon Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEHaleon US Holdings LLC7f367927-c366-465c-a059-e2cfb337d5622025-06-11WarningsExact identifier
application number: M001
Calmicid AC Acid ReducerFAMOTIDINEMelaleuca, Inc.369ae213-cd23-57ba-e063-6394a90a87a62025-06-02WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
application number: M001
Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.a7831b84-1f51-9258-e053-2a95a90a901e2025-05-23WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEAtlantic Biologicals Corps38654d22-2f8a-49d2-a1cd-06d341f113232025-05-12WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667489calcium carbonate 200 MG Oral LozengePSNf561685a-5260-59c6-e053-2a95a90ae20611
2204565pectin 11.5 MG Throat PopPSNf561685a-5260-59c6-e053-2a95a90ae20611
2667489calcium carbonate 200 MG Oral LozengeSCDf561685a-5260-59c6-e053-2a95a90ae20611
2204565pectin 11.5 MG Oral LozengeSCDf561685a-5260-59c6-e053-2a95a90ae20611
2204565pectin 11.5 MG Throat PopSYf561685a-5260-59c6-e053-2a95a90ae20611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72427-2000-0724272000007140 g in 1 BOX (72427-2000-0) 7140 g2019-06-21NoNoCurrent