FDA.reportPublic FDA data

Alka-Seltzer Heartburn Relief Extra Strength

Product NDC
0280-0079
Requested package NDC
0280-0079-01
11-digit product format
002800079
Labeler code
0280
Product ID
0280-0079_30155636-9069-f8ae-e063-6394a90a54a4
Type
HUMAN OTC DRUG
Nonproprietary name
Anhydrous citric acid, Sodium bicarbonate (heat-treated)
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Bayer Healthcare LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-21
Substance
SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE
Active strength
1976; 1000 mg/1; mg/1
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], 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

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 packagepackage0280-00790280-0079-01DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
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…

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
Alka-Seltzer Heartburn Relief Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE1976 mg/1
CITRIC ACID MONOHYDRATE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup
2968PHW8QPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2571087Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc1641f8-54c2-0d86-e053-2995a90a1dceAvailable 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
0280-0079-01Alka-Seltzer Heartburn Relief Extra Strength2 in 1 PACKETTABLET, EFFERVESCENT210
0280-0079-01Alka-Seltzer Heartburn Relief Extra Strength12 in 1 CARTONTABLET, EFFERVESCENT1210
0280-0079-02Alka-Seltzer Heartburn Relief Extra Strength2 in 1 PACKETTABLET, EFFERVESCENT210
0280-0079-02Alka-Seltzer Heartburn Relief Extra Strength36 in 1 CARTONTABLET, EFFERVESCENT3610
0280-0079-03Alka-Seltzer Heartburn Relief Extra Strength18 in 1 CARTONTABLET, EFFERVESCENT1810
0280-0079-03Alka-Seltzer Heartburn Relief Extra Strength2 in 1 PACKETTABLET, EFFERVESCENT210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0079ALKA-SELTZER HEARTBURN RELIEF EXTRA STRENGTH (ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC]10Current NDC, Legacy NDC, 6 package rows20250313_dc1641f8-54c2-0d86-e053-2995a90a1dce.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 21 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.043207dd-5e1c-4c78-b75a-7d341d71b1172025-05-12WarningsExact identifier
application number: M001
Calcium CarbonateANTACIDAllegiant Health5397b702-5920-4af9-8cc5-e7fe6e2c10212025-05-01WarningsExact identifier
application number: M001
Caring Mill AntacidCARING MILL ANTACID CHERRY FLAVOR SOFT CHEWSXiamen Kang Zhongyuan Biotechnology Co., Ltd.2669b4f9-82c6-8a39-e063-6394a90a0fd42025-04-30WarningsExact identifier
application number: M001
NauzeneSODIUM CITRATEKobayashi Healthcare International, Inc.a60660b2-c5db-45a0-885f-de93e655380d2025-04-29WarningsExact identifier
application number: M001
Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEFSA STORE INC.e07b3ec8-c2c7-41da-8374-12fe9f09d8562025-04-18WarningsExact identifier
application number: M001
Mag 440MEGNESIUM OXIDEAllegis Pharmaceuticals, LLC2cb19dc0-115b-38b8-e063-6294a90a4aea2025-04-17WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Mixed BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.3884c05a-a593-424e-88b3-be962e73488e2025-04-10WarningsExact identifier
application number: M001
Kroger Wild Berry Antacid ChewsCALCIUM CARBONATEKroger326e3775-d7f9-2fd9-e063-6294a90a059b2025-04-10WarningsExact identifier
application number: M001
Calcium Carbonate 750 mgCALCIUM CARBONATE 750 MG - ASSORTED BERRIESCVS Pharmacy.Inc.23a76a4f-8c41-b9d0-e063-6394a90a19c52025-04-09WarningsExact identifier
application number: M001
BERKLEY JENSEN ULTRA STRENGTHANTACID CALCIUM CARBONATEBJWCc7eedcbf-3b07-4cd3-937b-c56d7cc5bc572025-04-08WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth Dissolving - Assorted FruitCALCIUM CARBONATETARGET CORPORATION28fc38a7-f7a0-a6a5-e063-6294a90af94c2025-04-05WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth dissolving - Berry Fusion FlavorsCALCIUM CARBONATETARGET CORPORATION28fce33f-c561-1512-e063-6294a90a111c2025-04-05WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBelleview Biosciences31bc45c7-ba92-bad0-e063-6394a90a9af82025-04-01WarningsExact identifier
application number: M001
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATERite Aid840a617d-d006-4a9b-b98a-8a5ed9af0f402025-03-31WarningsExact identifier
application number: M001
Ultra Strength Antacid PeppermintCALCIUM CARBONATERite Aid3cb46f74-7a62-4b27-beac-a3c055a282152025-03-31WarningsExact identifier
application number: M001
Calcium Carbonate 1000 mgCALCIUM CARBONATE 1000 MG - TROPICAL FRUITCVS HEALTH CORP24ceba32-eb32-902f-e063-6394a90a9fd52025-03-28WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERite Aidb1af099d-4095-4bd7-a23c-ad85e92513d82025-03-28WarningsExact identifier
application number: M001
Extra Strength Antacid Orange Cream Sugar FreeCALCIUM CARBONATERite Aid089a1cd5-954e-4c3f-ab4b-cac693a1d44a2025-03-28WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2571087citric acid 1000 MG / sodium bicarbonate 1976 MG Effervescent Oral TabletPSNdc1641f8-54c2-0d86-e053-2995a90a1dce10
2571087citric acid 1000 MG / sodium bicarbonate 1976 MG Effervescent Oral TabletSCDdc1641f8-54c2-0d86-e053-2995a90a1dce10
2571087citric acid 1000 MG / NaHCO3 1976 MG Effervescent Oral TabletSYdc1641f8-54c2-0d86-e053-2995a90a1dce10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0079-010028000790112 PACKET in 1 CARTON (0280-0079-01) / 2 TABLET, EFFERVESCENT in 1 PACKET12 packet2021-09-210000-00-00NoNoCurrent