FDA.reportPublic FDA data

Aspirin

Product NDC
46122-596
11-digit product format
461220596
Labeler code
46122
Product ID
46122-596_1bb432eb-f97e-4771-af70-c0c85c7af424
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467

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
46122-596-02Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE110
46122-596-02Aspirin125 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-596ASPIRIN TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]9Current NDC, Legacy NDC, 2 package rows20250108_c3099892-a8cd-4574-a6f9-041e59e2feae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNc3099892-a8cd-4574-a6f9-041e59e2feae10
198467aspirin 325 MG Delayed Release Oral TabletSCDc3099892-a8cd-4574-a6f9-041e59e2feae10
198467ASA 325 MG Delayed Release Oral TabletSYc3099892-a8cd-4574-a6f9-041e59e2feae10
198467aspirin 325 MG Enteric Coated Oral TabletSYc3099892-a8cd-4574-a6f9-041e59e2feae10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-596-02461220596021 BOTTLE, PLASTIC in 1 CARTON (46122-596-02) / 125 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-06-010000-00-00NoNoCurrent