FDA.reportPublic FDA data

Alka-Seltzer Original

Product NDC
70264-014
11-digit product format
702640014
Labeler code
70264
Product ID
70264-014_43c89573-4cf2-997f-e063-6394a90a76ca
Type
HUMAN OTC DRUG
Nonproprietary name
ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
R J General Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-02
Substance
ASPIRIN; SODIUM BICARBONATE; ANHYDROUS CITRIC ACID
Active strength
325; 1916; 1000 mg/1; mg/1; mg/1
Pharmacologic classes
Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70264-014-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70264-014-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70264-014-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70264-014-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70264-014-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70264-014-019bebd1f3094a…5416666fcb17…

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 Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
SODIUM BICARBONATE1916 mg/1
ANHYDROUS CITRIC ACID1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
8MDF5V39QOInternal UNII lookup
XF417D3PSLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536675Internal RxNorm lookup
1536680Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbb0d067-71f0-45e4-bc98-548cf4a90b3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70264-014-012022-12-26C16284748780-19d75b9d0-63e5-f424-e053-dadaa90a57ceAlka-Seltzer ® Original
70264-014-012020-01-31C16284748780-19d75b9d0-63e5-f424-e053-dadaa90a57ceAlka-Seltzer ® Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-014-01Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT26
70264-014-01Alka-Seltzer Original50 in 1 CARTONTABLET, EFFERVESCENT506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-014ALKA-SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [R J GENERAL CORPORATION]5Current NDC, Legacy NDC, 2 package rows20241030_dbb0d067-71f0-45e4-bc98-548cf4a90b3a.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 28 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTH, TRAVEL BASIXACETAMINOPHENLil' Drug Store Products, Inc.fa951d50-b79c-4161-8c81-fcf386b0964e2025-12-15WarningsExact identifier
application number: M013
Vanquish Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEDSE Healthcare Solutions, LLCcbf12223-ef44-494b-9d3c-971dce3c5ade2025-12-15WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8bc75bcf-01c9-41d0-a96f-77a24e3edf012025-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS40a1b354-9b2e-1cf3-e063-6394a90af1132025-12-13WarningsExact identifier
application number: M013
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
application number: M013
Pain Reliever, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN TABLETLil' Drug Store Products, Inc.45c397bd-a1ff-1246-e063-6394a90ac54a2025-12-12WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c7c11b-d627-aee8-e063-6294a90a401d2025-12-12WarningsExact identifier
application number: M013
AspirinASPIRINTOP CARE (Topco Associates LLC)d3df90be-9037-44b2-bf48-540d68a033b22025-12-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINHy-Vee98ab6fb7-c7e5-45ab-97c3-81d422f8a8432025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma33599f18-5f49-4f22-8a77-a072115763ef2025-12-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINVALU MERCHANDISERS COMPANY746059b3-ed18-4a81-a70e-4d758e048d8e2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY005e299e-aa84-49d9-bbca-12236f865a272025-12-11WarningsExact identifier
application number: M013
Low Dose Chewable AspirinASPIRINVALU MERCHANDISERS COMPANY7d88f156-d361-4249-b70d-4bbcd5ba30b72025-12-11WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINVALU MERCHANDISERS COMPANYcc18e8e1-652e-44da-a9d7-e56cebda55a12025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYd4c32e70-778a-4d66-b9d0-03944a5284212025-12-11WarningsExact identifier
application number: M013
adult low dose aspirinASPIRINVALU MERCHANDISERS COMPANY6fa1c707-bd42-455b-90a3-2c2a11acc6832025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY5a80cb17-7731-4457-acd3-64cf4accf8622025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENVALU MERCHANDISERS COMPANY02e3798f-86d9-64b4-e063-6294a90a29de2025-12-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSNdbb0d067-71f0-45e4-bc98-548cf4a90b3a6
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSNdbb0d067-71f0-45e4-bc98-548cf4a90b3a6
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBDdbb0d067-71f0-45e4-bc98-548cf4a90b3a6
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCDdbb0d067-71f0-45e4-bc98-548cf4a90b3a6
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSYdbb0d067-71f0-45e4-bc98-548cf4a90b3a6
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSYdbb0d067-71f0-45e4-bc98-548cf4a90b3a6
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SYdbb0d067-71f0-45e4-bc98-548cf4a90b3a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70264-014-017026400140150 POUCH in 1 CARTON (70264-014-01) / 2 TABLET, EFFERVESCENT in 1 POUCH50 pouch2010-03-020000-00-00NoNoCurrent