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

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 Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui2606079

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

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