FDA.reportPublic FDA data

Sodium Bicarbonate 10 gr

Product NDC
69618-034
Requested package NDC
69618-034-10
11-digit product format
696180034
Labeler code
69618
Product ID
69618-034_2bc8028b-eebb-902f-e063-6394a90a382b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
TABLET, SOLUBLE
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
SODIUM BICARBONATE
Active strength
648 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

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Bicarbonate 10 gr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE648 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
321a772c-c44c-3d4e-e054-00144ff8d46cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-034-102023-01-30C16284748780-1f386c64a-1db3-0266-e053-dadaa90a7c1aSodium Bicarbonate 10 gr

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-034-10Sodium Bicarbonate 10 gr1000 in 1 BOTTLE, PLASTICTABLET, SOLUBLE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-034-10EA - Each69618-0348774e945-56f9-47f5-8fab-22387140da4312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-034SODIUM BICARBONATE 10 GR (SODIUM BICARBONATE) TABLET, SOLUBLE [RELIABLE 1 LABORATORIES LLC]6Current NDC, Legacy NDC, 1 package rows20250117_321a772c-c44c-3d4e-e054-00144ff8d46c.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 25 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
application number: M001
Goodsense Ultra Strength AntacidCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)492deace-7ea1-4fe3-a4c7-b2c6f195d68c2025-01-20WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
application number: M001
GoodSense Extra Strength AntacidCALCIUM CARBONATEGoodSense2fcdeb06-17de-49d8-97bb-8d31e1c0c61f2025-01-20WarningsExact identifier
application number: M001
HEB Extra Stregth AntacidCALCIUM CARBONATEH E Bdcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e482025-01-20WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEEverpharm LLC2bda74cb-e77d-46bb-e063-6394a90af5802025-01-16WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATECVS1bf90c0c-b639-1c06-e063-6394a90ab85b2025-01-16WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEReliable 1 Laboratories LLC321a772c-c44c-3d4e-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
ndc (package): 69618-034-10
ndc (product): 69618-034
ndc11 (package): 69618003410
Calcium Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
application number: M001
Rolaids Extra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e2025-01-15WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEH E B19a3221f-e0c1-c47a-e063-6394a90a1f012025-01-14WarningsExact identifier
application number: M001
Childrens Stomach Relief AntacidCALCIUM CARBONATEH E B18fae1aa-1001-8035-e063-6394a90adc662025-01-14WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Aphena Pharma Solutions - Tennessee, LLCac839363-94fd-4c60-b5b6-70e4488ce1dd2025-01-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN321a772c-c44c-3d4e-e054-00144ff8d46c6
198861sodium bicarbonate 650 MG Oral TabletSCD321a772c-c44c-3d4e-e054-00144ff8d46c6
198861NaHCO3 650 MG Oral TabletSY321a772c-c44c-3d4e-e054-00144ff8d46c6
198861sodium bicarbonate 10 Grains Oral TabletSY321a772c-c44c-3d4e-e054-00144ff8d46c6
198861sodium bicarbonate 648 MG Oral TabletSY321a772c-c44c-3d4e-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-034-10696180034101000 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (69618-034-10) 2015-11-010000-00-00NoNoCurrent