Aspirin

Product NDC
55910-945
11-digit product format
559100945
Labeler code
55910
Product ID
55910-945_ca995f51-6856-427c-8ee1-26be4a0f1ad3
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-25
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
7396c97e-8a51-4a21-8208-f13258b5285cAvailable 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
55910-945-12AspirinLow Dose100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10013
55910-945-12AspirinLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-945ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]12Current NDC, Legacy NDC, 2 package rows20241116_7396c97e-8a51-4a21-8208-f13258b5285c.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 24 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Relief Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEUnited Natural Foods, Inc. dba UNFI807598ef-9f03-48df-b076-3ee95ef4b06c2026-01-05WarningsExact identifier
application number: M013
Pain Relief Extra Strength, Non-AspirinACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1fb5e871-45fd-46fe-bf73-5192f8316e8e2026-01-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENValu Merchandisers Company0005aafa-08f8-4990-a54d-cc097195708f2026-01-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENWalmart Inc.152bb455-da5b-ae13-e063-6394a90acab02026-01-01WarningsExact identifier
application number: M013
Dr. Cocoa for Children Pain and FeverACETAMINOPHENInfirst Healthcare Inc.486ea294-6d18-a907-e063-6294a90ad2842026-01-01WarningsExact identifier
application number: M013
ED APAPACETAMINOPHENEDWARDS PHARMACEUTICALS, INC.f76d5fff-ebea-40f9-aad3-4064a0c863f02025-12-31WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP99ec63ef-aa28-c2fb-e053-2a95a90a9f6d2025-12-31WarningsExact identifier
application number: M013
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
application number: M013
Liquid AcetaminophenACETAMINOPHENLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONa7dbd4c0-53eb-4368-917b-1432c09ce6b42025-12-31WarningsExact identifier
application number: M013
Llorens Care Children AcetaminophenACETAMINOPHENLlorens Pharmaceutical International Division, Inc.2a46d7d2-293b-5024-e063-6294a90a31aa2025-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)Walgreens3a801457-c5d0-b134-e063-6294a90ac5cb2025-12-31WarningsExact identifier
application number: M013
Daytime and Nighttime Severe Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGenexa Inc.190c7eaf-dcd4-d314-e063-6294a90a6f332025-12-30WarningsExact identifier
application number: M013
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLC0181af13-da32-4431-be39-c31fdfac92022025-12-29WarningsExact identifier
application number: M013
Gemma Cut the CrampASPIRIN, CAFFEINERally Labs LLC16c9a296-077a-8e12-e063-6294a90a1b8b2025-12-29WarningsExact identifier
application number: M013
BlowfishASPIRIN, CAFFEINERally Labs LLC0d3798bc-04ef-584e-821b-7aa76036b7d12025-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
application number: M013
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN7396c97e-8a51-4a21-8208-f13258b5285c13
308416aspirin 81 MG Delayed Release Oral TabletSCD7396c97e-8a51-4a21-8208-f13258b5285c13
308416ASA 81 MG Delayed Release Oral TabletSY7396c97e-8a51-4a21-8208-f13258b5285c13
308416aspirin 81 MG Enteric Coated Oral TabletSY7396c97e-8a51-4a21-8208-f13258b5285c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-945-12559100945121 BOTTLE, PLASTIC in 1 CARTON (55910-945-12) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2014-07-250000-00-00NoNoCurrent