FDA.reportPublic FDA data

NUTRALOX

Product NDC
50332-0106
Requested package NDC
50332-0106-1
11-digit product format
503320106
Labeler code
50332
Product ID
50332-0106_7c0948f2-8cf5-4f32-a823-f7a27e6a04ce
Type
HUMAN OTC DRUG
Nonproprietary name
CALCIUM CARBONATE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
HART Health
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1987-01-20
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE
Active strength
420 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50332-010650332-0106-1IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDCEffectiveRelated label
50332-0106-12022-01-28NUTRALOX
50332-0106-32022-01-28NUTRALOX
50332-0106-42022-01-28NUTRALOX
50332-0106-72022-01-28NUTRALOX
50332-0106-82022-01-28NUTRALOX
50332-0106-12020-06-05NUTRALOX
50332-0106-32020-06-05NUTRALOX
50332-0106-42020-06-05NUTRALOX
50332-0106-72020-06-05NUTRALOX
50332-0106-82020-06-05NUTRALOX
50332-0106-12020-01-31NUTRALOX
50332-0106-32020-01-31NUTRALOX
50332-0106-42020-01-31NUTRALOX
50332-0106-72020-01-31NUTRALOX
50332-0106-82020-01-31NUTRALOX

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKNUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBNUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BNUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]1
SUCROSEINACTIVE INGREDIENTC151H8M554NUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0106NUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]3Legacy NDC20200607_263e20ca-1ca6-4f7c-bae5-525a1184b744.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN524e26a9-c69f-4e25-b83d-f4c65adca83d11
1358869Nutralox 420 MG Chewable TabletPSN524e26a9-c69f-4e25-b83d-f4c65adca83d11
1358869calcium carbonate 420 MG Chewable Tablet [Nutralox]SBD524e26a9-c69f-4e25-b83d-f4c65adca83d11
313884calcium carbonate 420 MG Chewable TabletSCD524e26a9-c69f-4e25-b83d-f4c65adca83d11
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY524e26a9-c69f-4e25-b83d-f4c65adca83d11
1358869Nutralox 420 MG Chewable TabletSY524e26a9-c69f-4e25-b83d-f4c65adca83d11
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN263e20ca-1ca6-4f7c-bae5-525a1184b7443
1358869Nutralox 420 MG Chewable TabletPSN263e20ca-1ca6-4f7c-bae5-525a1184b7443
1358869calcium carbonate 420 MG Chewable Tablet [Nutralox]SBD263e20ca-1ca6-4f7c-bae5-525a1184b7443
313884calcium carbonate 420 MG Chewable TabletSCD263e20ca-1ca6-4f7c-bae5-525a1184b7443
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY263e20ca-1ca6-4f7c-bae5-525a1184b7443
1358869Nutralox 420 MG Chewable TabletSY263e20ca-1ca6-4f7c-bae5-525a1184b7443
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN5c5e1095-2a23-41a7-bdda-d286e0c2250e1
1358869Nutralox 420 MG Chewable TabletPSN5c5e1095-2a23-41a7-bdda-d286e0c2250e1
1358869calcium carbonate 420 MG Chewable Tablet [Nutralox]SBD5c5e1095-2a23-41a7-bdda-d286e0c2250e1
313884calcium carbonate 420 MG Chewable TabletSCD5c5e1095-2a23-41a7-bdda-d286e0c2250e1
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY5c5e1095-2a23-41a7-bdda-d286e0c2250e1
1358869Nutralox 420 MG Chewable TabletSY5c5e1095-2a23-41a7-bdda-d286e0c2250e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50332-0106-150332010601500 PACKET in 1 BOX, UNIT-DOSE (50332-0106-1) > 2 TABLET, CHEWABLE in 1 PACKET500 packet1987-01-200000-00-00NoNoCurrent