FDA.reportPublic FDA data

Aspirin

Product NDC
50844-600
11-digit product format
508440600
Labeler code
50844
Product ID
50844-600_97654157-7eeb-4ebf-bbef-c7596fff8cda
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
L.N.K. International, Inc.
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
50844-600-01AspirinLow Dose1 in 1 BOXTABLET, DELAYED RELEASE117
50844-600-01AspirinLow Dose30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3017
50844-600-14AspirinLow Dose500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50017
50844-600-17AspirinLow Dose300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30017
50844-600-17AspirinLow Dose1 in 1 BOXTABLET, DELAYED RELEASE117
50844-600-32AspirinLow Dose1 in 1 BOXTABLET, DELAYED RELEASE117
50844-600-32AspirinLow Dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12017
50844-600-95AspirinLow Dose300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]5
ASPIRINACTIVE INGREDIENTR16CO5Y76EADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
ASPIRINACTIVE MOIETYR16CO5Y76EADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71OADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-600ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [L.N.K. INTERNATIONAL, INC.]16Current NDC, Legacy NDC, 8 package rows20240619_2f6ec676-3832-420e-be91-fce83f6586c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN2f6ec676-3832-420e-be91-fce83f6586c817
308416aspirin 81 MG Delayed Release Oral TabletSCD2f6ec676-3832-420e-be91-fce83f6586c817
308416ASA 81 MG Delayed Release Oral TabletSY2f6ec676-3832-420e-be91-fce83f6586c817
308416aspirin 81 MG Enteric Coated Oral TabletSY2f6ec676-3832-420e-be91-fce83f6586c817
308416aspirin 81 MG Delayed Release Oral TabletPSN95c34d67-3a72-49d4-89aa-7186ac58c0dc2
308416aspirin 81 MG Delayed Release Oral TabletSCD95c34d67-3a72-49d4-89aa-7186ac58c0dc2
308416ASA 81 MG Delayed Release Oral TabletSY95c34d67-3a72-49d4-89aa-7186ac58c0dc2
308416aspirin 81 MG Enteric Coated Oral TabletSY95c34d67-3a72-49d4-89aa-7186ac58c0dc2
308416aspirin 81 MG Delayed Release Oral TabletPSN52435568-ccc6-4823-8abb-9b60a9a9216b1
308416aspirin 81 MG Delayed Release Oral TabletSCD52435568-ccc6-4823-8abb-9b60a9a9216b1
308416ASA 81 MG Delayed Release Oral TabletSY52435568-ccc6-4823-8abb-9b60a9a9216b1
308416aspirin 81 MG Enteric Coated Oral TabletSY52435568-ccc6-4823-8abb-9b60a9a9216b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-600-01508440600011 in 1 BOXHistorical
50844-600-1450844060014500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50844-600-14) 2011-05-01NoNoCurrent
50844-600-1750844060017300 in 1 BOTTLE, PLASTICHistorical
50844-600-32508440600321 BOTTLE, PLASTIC in 1 BOX (50844-600-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
50844-600-9550844060095300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50844-600-95) 2011-05-01NoNoCurrent