FDA.reportPublic FDA data

SODIUM BICARBONATE

Product NDC
43353-162
11-digit product format
433530162
Labeler code
43353
Product ID
43353-162_36d1abdc-f28b-4c0d-98ea-07718706c695
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
2015-05-01
Substance
SODIUM BICARBONATE
Active strength
650 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM BICARBONATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198861Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15605a6d-6c90-47d5-9d1f-f66a3f27d5fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-162-53SODIUM BICARBONATE60 in 1 BOTTLE, PLASTICTABLET601
43353-162-60SODIUM BICARBONATE90 in 1 BOTTLE, PLASTICTABLET901
43353-162-70SODIUM BICARBONATE120 in 1 BOTTLE, PLASTICTABLET1201
43353-162-80SODIUM BICARBONATE180 in 1 BOTTLE, PLASTICTABLET1801
43353-162-85SODIUM BICARBONATE200 in 1 BOTTLE, PLASTICTABLET2001
43353-162-94SODIUM BICARBONATE360 in 1 BOTTLE, PLASTICTABLET3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-162-53EA - Each43353-162dcb2723a-770a-422b-8313-e455e09f40c412024-03-12
43353-162-60EA - Each43353-16249abaeba-bad8-42a0-a95b-2229b21d50c012018-01-12
43353-162-70EA - Each43353-1620efac8d5-5828-4882-8da1-3c4c6526b16112018-01-12
43353-162-85EA - Each43353-162954b7489-dab4-44a9-be51-7afa6ffffa4f12018-01-12
43353-162-94EA - Each43353-1627da4f6f9-d28e-4169-a488-9c956cfa389812018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-162SODIUM BICARBONATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 6 package rows20171214_15605a6d-6c90-47d5-9d1f-f66a3f27d5fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsExact identifier
ndc (product): 43353-162

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN15605a6d-6c90-47d5-9d1f-f66a3f27d5fc1
198861sodium bicarbonate 650 MG Oral TabletSCD15605a6d-6c90-47d5-9d1f-f66a3f27d5fc1
198861NaHCO3 650 MG Oral TabletSY15605a6d-6c90-47d5-9d1f-f66a3f27d5fc1
198861sodium bicarbonate 10 Grains Oral TabletSY15605a6d-6c90-47d5-9d1f-f66a3f27d5fc1
198861sodium bicarbonate 648 MG Oral TabletSY15605a6d-6c90-47d5-9d1f-f66a3f27d5fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-162-534335301625360 TABLET in 1 BOTTLE, PLASTIC (43353-162-53) 60 tablet2016-03-300000-00-00NoNoCurrent
43353-162-604335301626090 TABLET in 1 BOTTLE, PLASTIC (43353-162-60) 90 tablet2016-02-220000-00-00NoNoCurrent
43353-162-7043353016270120 TABLET in 1 BOTTLE, PLASTIC (43353-162-70) 120 tablet2016-02-220000-00-00NoNoCurrent
43353-162-8043353016280180 TABLET in 1 BOTTLE, PLASTIC (43353-162-80) 180 tablet2016-03-300000-00-00NoNoCurrent
43353-162-8543353016285200 TABLET in 1 BOTTLE, PLASTIC (43353-162-85) 200 tablet2016-03-020000-00-00NoNoCurrent
43353-162-9443353016294360 TABLET in 1 BOTTLE, PLASTIC (43353-162-94) 360 tablet2016-02-220000-00-00NoNoCurrent