FDA.reportPublic FDA data

Sodium Bicarbonate

Product NDC
55154-6754
11-digit product format
551546754
Labeler code
55154
Product ID
55154-6754_8d3ae963-7b70-486e-a109-f973eb0ca636
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-06
Marketing end
0000-00-00
Substance
SODIUM BICARBONATE
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-6754DDiscontinued by firm2026-11-06
excluded packagepackage55154-675455154-6754-0DDiscontinued by firm2026-11-06

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55154-6754-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55154-6754-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55154-6754-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55154-6754-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55154-6754-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55154-6754-01332a3947898…d4bfe170f9cd…

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55154-6754-02024-11-08C16284748780-1f386c649-b3d1-0266-e053-dadaa90a7c1aSodium Bicarbonate 650 mg (10 grain)
55154-6754-02023-01-30C16284748780-1f386c649-b3d1-0266-e053-dadaa90a7c1aSodium Bicarbonate 650 mg (10 grain)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-6754-0Sodium Bicarbonate1 in 1 BLISTER PACKTABLET16
55154-6754-0Sodium Bicarbonate10 in 1 BAGTABLET106

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOSODIUM BICARBONATE TABLET [CARDINAL HEALTH]1
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20SODIUM BICARBONATE TABLET [CARDINAL HEALTH]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSODIUM BICARBONATE TABLET [CARDINAL HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSODIUM BICARBONATE TABLET [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6754SODIUM BICARBONATE TABLET [CARDINAL HEALTH 107, LLC]6Legacy NDC, 2 package rows20241109_f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198861sodium bicarbonate 650 MG Oral TabletPSNf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f6
198861sodium bicarbonate 650 MG Oral TabletSCDf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f6
198861NaHCO3 650 MG Oral TabletSYf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f6
198861sodium bicarbonate 10 Grains Oral TabletSYf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f6
198861sodium bicarbonate 648 MG Oral TabletSYf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-6754-05515467540010 BLISTER PACK in 1 BAG (55154-6754-0) > 1 TABLET in 1 BLISTER PACK10 blister pack2011-06-060000-00-00NoNoCurrent