FDA.reportPublic FDA data

Aspirin

Product NDC
0536-1054
11-digit product format
005361054
Labeler code
0536
Product ID
0536-1054_073e46e8-4175-46cc-b407-8c173f8b2a1d
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-02-10
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
Aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui212033

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
0536-1054-05Aspirin500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015
0536-1054-29Aspirin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015
0536-1054-29Aspirin1 in 1 CARTONTABLET, FILM COATED115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1054-05EA - Each0536-1054fc237185-1bbd-4a5e-bb81-7af422a69f9112021-06-02
0536-1054-29EA - Each0536-1054cadc1bc8-3468-44a1-9e73-8d4a6d8753e612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET [RUGBY LABORATORIES]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET [RUGBY LABORATORIES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET [RUGBY LABORATORIES]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN TABLET [RUGBY LABORATORIES]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN TABLET [RUGBY LABORATORIES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1054ASPIRIN TABLET, FILM COATED [RUGBY LABORATORIES]14Current NDC, Legacy NDC, 3 package rows20250315_f7ca9f4a-f8ef-46d2-9536-b69541e6653d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSNf7ca9f4a-f8ef-46d2-9536-b69541e6653d15
212033aspirin 325 MG Oral TabletSCDf7ca9f4a-f8ef-46d2-9536-b69541e6653d15
212033ASA 325 MG Oral TabletSYf7ca9f4a-f8ef-46d2-9536-b69541e6653d15
212033aspirin 325 MG Oral TabletPSN12feb32b-4b8c-4b17-9e86-cb286457b0883
212033aspirin 325 MG Oral TabletSCD12feb32b-4b8c-4b17-9e86-cb286457b0883
212033ASA 325 MG Oral TabletSY12feb32b-4b8c-4b17-9e86-cb286457b0883
198467aspirin 325 MG Delayed Release Oral TabletPSN2553d0cb-3f5c-7ea0-e063-6294a90a3cd42
198467aspirin 325 MG Delayed Release Oral TabletSCD2553d0cb-3f5c-7ea0-e063-6294a90a3cd42
198467ASA 325 MG Delayed Release Oral TabletSY2553d0cb-3f5c-7ea0-e063-6294a90a3cd42
198467aspirin 325 MG Enteric Coated Oral TabletSY2553d0cb-3f5c-7ea0-e063-6294a90a3cd42
212033aspirin 325 MG Oral TabletPSN9c186289-e309-45e8-8934-1d0eae0375c21
212033aspirin 325 MG Oral TabletSCD9c186289-e309-45e8-8934-1d0eae0375c21
212033ASA 325 MG Oral TabletSY9c186289-e309-45e8-8934-1d0eae0375c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1054-0500536105405500 TABLET in 1 BOTTLE, PLASTIC (0536-1054-05) 500 tablet1996-02-100000-00-00NoNoCurrent
0536-1054-29005361054291 BOTTLE, PLASTIC in 1 CARTON (0536-1054-29) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1996-02-100000-00-00NoNoCurrent