Sodium Bicarbonate

Product NDC
71610-438
Requested package NDC
71610-438-94
11-digit product format
716100438
Labeler code
71610
Product ID
71610-438_8c2fd216-d341-4bfb-a25b-6e04602d34bb
Type
HUMAN OTC DRUG
Nonproprietary name
sodium bicarbonate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-02-01
Marketing end
0000-00-00
Substance
SODIUM BICARBONATE
Active strength
650 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 packagepackage71610-43871610-438-94IInactivated by FDA2026-10-15

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 · 9 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 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-438-53Sodium Bicarbonate60 in 1 BOTTLETABLET601
71610-438-60Sodium Bicarbonate90 in 1 BOTTLETABLET901
71610-438-80Sodium Bicarbonate180 in 1 BOTTLETABLET1801
71610-438-94Sodium Bicarbonate360 in 1 BOTTLETABLET3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-438-53EA - Each71610-4388efe719b-7b96-420f-85ef-b082d4a715ea12020-08-06
71610-438-60EA - Each71610-43899a9a712-4830-43a2-81c0-1de3b46d277212020-08-06
71610-438-80EA - Each71610-4387fe21e47-d911-4b48-833c-75e4f30a7beb12020-08-06
71610-438-94EA - Each71610-43821a47732-b56f-4fb9-9c74-7a5fcb078be512020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-438SODIUM BICARBONATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20200709_f7ebb41a-d483-442a-95a0-47706cf3ee9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198861sodium bicarbonate 650 MG Oral TabletPSNf7ebb41a-d483-442a-95a0-47706cf3ee9a1
198861sodium bicarbonate 650 MG Oral TabletSCDf7ebb41a-d483-442a-95a0-47706cf3ee9a1
198861NaHCO3 650 MG Oral TabletSYf7ebb41a-d483-442a-95a0-47706cf3ee9a1
198861sodium bicarbonate 10 Grains Oral TabletSYf7ebb41a-d483-442a-95a0-47706cf3ee9a1
198861sodium bicarbonate 648 MG Oral TabletSYf7ebb41a-d483-442a-95a0-47706cf3ee9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-438-9471610043894360 TABLET in 1 BOTTLE (71610-438-94) 360 tablet2020-06-230000-00-00NoNoCurrent