FDA.reportPublic FDA data

Extra Strength Antacid Tropical Fruit

Product NDC
83455-127
11-digit product format
834550127
Labeler code
83455
Product ID
83455-127_2d7647f6-821c-4848-afff-908501746d3a
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
UNITED NATURAL FOODS, INC. DBA UNFI
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-06
Substance
CALCIUM CARBONATE
Active strength
750 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

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Antacid Tropical Fruit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui308915

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
83455-127-22Extra Strength Antacid Tropical Fruit96 in 1 BOTTLETABLET, CHEWABLE962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83455-127EXTRA STRENGTH ANTACID TROPICAL FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [UNITED NATURAL FOODS, INC. DBA UNFI]2Current NDC, 1 package rows20250210_1b6a28a2-f848-d185-e063-6294a90ab338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1b6a28a2-f848-d185-e063-6294a90ab3382
308915calcium carbonate 750 MG Chewable TabletSCD1b6a28a2-f848-d185-e063-6294a90ab3382
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY1b6a28a2-f848-d185-e063-6294a90ab3382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83455-127-228345501272296 TABLET, CHEWABLE in 1 BOTTLE (83455-127-22) 2025-02-06NoNoCurrent