FDA.reportPublic FDA data

Aspirin

Product NDC
50844-600
Requested package NDC
50844-600-32
11-digit product format
508440600
Labeler code
50844
Product ID
50844-600_62d04705-d057-45a8-b5c3-18c9c82caa65
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f6ec676-3832-420e-be91-fce83f6586c8Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 79 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
application number: M013
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
application number: M013
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
application number: M013

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
50844-600-32508440600321 BOTTLE, PLASTIC in 1 BOX (50844-600-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent