FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
46122-761
11-digit product format
461220761
Labeler code
46122
Product ID
46122-761_91608935-b4de-43e1-8775-e97c89344070
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-15
Marketing end
2027-01-28
Substance
ASPIRIN
Active strength
81 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Low Dose Aspirin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

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
46122-761-58Low Dose Aspirin1 in 1 BOXTABLET, COATED14
46122-761-58Low Dose Aspirin120 in 1 BOTTLE, PLASTICTABLET, COATED1204
46122-761-61Low Dose Aspirin300 in 1 BOTTLE, PLASTICTABLET, COATED3004
46122-761-61Low Dose Aspirin1 in 1 BOXTABLET, COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-761-58EA - Each46122-761f5cbaf3b-dd39-467a-8bfb-c2eb729101a112023-10-16
46122-761-61EA - Each46122-76147f45226-7b72-402e-a035-b91fb70b0e5412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-761LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]2Current NDC, 4 package rows20240208_db187226-0770-4934-90a4-c6ca50bdecef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNdb187226-0770-4934-90a4-c6ca50bdecef4
308416aspirin 81 MG Delayed Release Oral TabletSCDdb187226-0770-4934-90a4-c6ca50bdecef4
308416ASA 81 MG Delayed Release Oral TabletSYdb187226-0770-4934-90a4-c6ca50bdecef4
308416aspirin 81 MG Enteric Coated Oral TabletSYdb187226-0770-4934-90a4-c6ca50bdecef4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-761-58461220761581 BOTTLE, PLASTIC in 1 BOX (46122-761-58) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC2023-06-152027-01-28NoNoHistorical
46122-761-61461220761611 BOTTLE, PLASTIC in 1 BOX (46122-761-61) / 300 TABLET, COATED in 1 BOTTLE, PLASTIC2023-06-152027-01-28NoNoHistorical