SODIUM BICARBONATE

Product NDC
52682-206
11-digit product format
526820206
Labeler code
52682
Product ID
52682-206_c4718b91-3d55-4894-a6c4-20c3838e74a9
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM BICARBONATE
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals NJ, LLC
Application
part331
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-01-24
Marketing end
2025-04-01
Substance
SODIUM BICARBONATE
Active strength
650 mg/1
Pharmacologic classes
Alkalinizing Activity [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct52682-206DDiscontinued by firm2026-10-16
excluded packagepackage52682-20652682-206-04DDiscontinued by firm2026-10-16

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52682-206-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52682-206-04f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52682-206-04526820206041000 TABLET in 1 BOTTLE, PLASTIC (52682-206-04) 1000 tablet2011-01-240000-00-00NoNoCurrent