FDA.reportPublic FDA data

Premier Value Smooth Antacid Extra Strength

Product NDC
68016-675
11-digit product format
680160675
Labeler code
68016
Product ID
68016-675_0b9b9a00-e473-4b9b-ad0e-b36451371cb7
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Chain Drug Consortium
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-07
Substance
CALCIUM CARBONATE
Active strength
500 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
Premier Value Smooth Antacid Extra Strength
Brand name suffix
Assorted Fruit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui308907

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-675-002021-10-13C16284748780-1ba0f9c33-3291-a910-e053-dadaa90a0b85Premier Value Extra Strength Smooth Antacid
68016-675-002021-01-29C16284748780-1ba0f9c33-3291-a910-e053-dadaa90a0b85Premier Value Extra Strength Smooth Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-675-00Premier Value Smooth Antacid Extra StrengthAssorted Fruit90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-675PREMIER VALUE SMOOTH ANTACID EXTRA STRENGTH ASSORTED FRUIT (ANTACID TABLETS) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]6Current NDC, Legacy NDC, 1 package rows20241030_0de2c4c5-46fb-4081-aa96-b36794e3983f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN0de2c4c5-46fb-4081-aa96-b36794e3983f6
308907calcium carbonate 500 MG Chewable TabletSCD0de2c4c5-46fb-4081-aa96-b36794e3983f6
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY0de2c4c5-46fb-4081-aa96-b36794e3983f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-675-006801606750090 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68016-675-00) 2014-02-070000-00-00NoNoCurrent