FDA.reportPublic FDA data

Alka-Seltzer Original Flavor

Product NDC
67751-219
11-digit product format
677510219
Labeler code
67751
Product ID
67751-219_23960e84-c184-a473-e063-6394a90ad146
Type
HUMAN OTC DRUG
Nonproprietary name
Alka-Seltzer Original Flavor
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-16
Substance
ASPIRIN
Active strength
325 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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

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 Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2606079Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f70875ab-241c-4876-e053-6294a90a8092Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-219-01Alka-Seltzer Original Flavor1 in 1 CARTONTABLET, EFFERVESCENT12
67751-219-01Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT22
67751-219-02Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT22
67751-219-02Alka-Seltzer Original Flavor2 in 1 CARTONTABLET, EFFERVESCENT22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-219ALKA-SELTZER ORIGINAL FLAVOR TABLET, EFFERVESCENT [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 4 package rows20241004_f70875ab-241c-4876-e053-6294a90a8092.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 53 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6fee238-0b6f-cb84-e053-2995a90a361b2024-12-05WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEL.N.K. International, Inc.379ef03c-3b6a-40c3-b736-99f0537d26c82024-12-05WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENMarc Glassman, Inc.43bf297f-2832-424f-a013-4bfa1d6c03e62024-12-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.5a68ab98-720c-479a-a60a-4e594add6c092024-12-04WarningsExact identifier
application number: M013
HEB Effervescent Pain ReliefASPIRINH. E. BUTT GROCERY COMPANY03876c71-60ec-3280-e063-6294a90a62dc2024-12-03WarningsExact identifier
application number: M013
Migrafein FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028875c9-4129-ce2c-e063-6294a90a26cc2024-12-03WarningsExact identifier
application number: M013
Neo-Lubrina FuerteACETAMINOPHEN, CAFFEINEOPMX LLC0288a327-fd4b-1991-e063-6294a90ace502024-12-03WarningsExact identifier
application number: M013
CAFIZETAMOL FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028771d3-a514-f7a5-e063-6394a90ac4f32024-12-03WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC048c4b03-1cf4-b724-e063-6294a90a1cad2024-12-03WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCecd6df7e-e7e2-446b-85ef-25971281fe312024-12-03WarningsExact identifier
application number: M013
Market Basket Effervescent Pain ReliefASPIRINDEMOULAS SUPER MARKETS, INC.08133bf0-3c8f-e4d0-e063-6294a90af79a2024-12-03WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWinCo Foods, LLC4359da13-e851-440b-91b9-6b544bff20d22024-12-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWinCo Foods, LLC5b3e8a78-5357-42ad-811e-b2578b25dc7b2024-12-03WarningsExact identifier
application number: M013
Low Strength Chewable AspirinASPIRINGeri-Care Pharmaceutical Corpcc77b9d1-7874-4ce8-a763-3a0e1c2891de2024-12-03WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENL. Perrigo Companyc6b79501-d08b-4430-9545-70da5f5459752024-12-03WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association0e3be5f4-bc1b-4b44-a86a-ace89f6ee5922024-12-02WarningsExact identifier
application number: M013
St. Joseph Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.c0c31523-c4c5-43c2-8d72-4d1456c720e92024-12-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSNf70875ab-241c-4876-e053-6294a90a80922
2606079aspirin 325 MG Effervescent Oral TabletSCDf70875ab-241c-4876-e053-6294a90a80922
2606079ASA 325 MG Effervescent Oral TabletSYf70875ab-241c-4876-e053-6294a90a80922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67751-219-01677510219011 POUCH in 1 CARTON (67751-219-01) / 2 TABLET, EFFERVESCENT in 1 POUCH1 pouch2023-03-16NoNoCurrent
67751-219-02677510219022 POUCH in 1 CARTON (67751-219-02) / 2 TABLET, EFFERVESCENT in 1 POUCH2 pouch2023-03-16NoNoCurrent