FDA.reportPublic FDA data

Aspirin

Product NDC
55301-600
11-digit product format
553010600
Labeler code
55301
Product ID
55301-600_0e484356-315d-436c-9fb0-506b3cab62b1
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-01
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
Low Dose
Listing expiration
2026-12-31

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
55301-600-32AspirinLow Dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12016
55301-600-32AspirinLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE116
55301-600-51AspirinLow Dose365 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE36516

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-600ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [ARMY AND AIR FORCE EXCHANGE SERVICE]15Current NDC, Legacy NDC, 3 package rows20240616_e273ead7-7cbc-4fd5-a136-9d3558a35360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNe273ead7-7cbc-4fd5-a136-9d3558a3536016
308416aspirin 81 MG Delayed Release Oral TabletSCDe273ead7-7cbc-4fd5-a136-9d3558a3536016
308416ASA 81 MG Delayed Release Oral TabletSYe273ead7-7cbc-4fd5-a136-9d3558a3536016
308416aspirin 81 MG Enteric Coated Oral TabletSYe273ead7-7cbc-4fd5-a136-9d3558a3536016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-600-32553010600321 BOTTLE, PLASTIC in 1 CARTON (55301-600-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
55301-600-5155301060051365 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55301-600-51) 2011-05-010000-00-00NoNoCurrent