FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
41163-563
11-digit product format
411630563
Labeler code
41163
Product ID
41163-563_180c7e2b-b245-43e4-a26d-4e8b083d7a86
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
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
Low Dose Aspirin
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
41163-563-06Low Dose Aspirin200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE20018
41163-563-06Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE118
41163-563-17Low Dose Aspirin300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30018
41163-563-17Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE118
41163-563-32Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE118
41163-563-32Low Dose Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-563-06EA - Each41163-563b0f33405-6341-4b52-8eaa-c64cb4be99b912013-02-13
41163-563-17EA - Each41163-5630a45f9f0-4d46-45a2-8a10-18af3e29e83112013-02-13
41163-563-32EA - Each41163-5632fd36421-cb45-4f78-be8d-c06e0f9e9c9b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
ASPIRINACTIVE MOIETYR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLOW DOSE ASPIRIN (ASPIRIN) TABLET [SUPERVALU INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-563LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]17Current NDC, Legacy NDC, 6 package rows20250101_18b79449-5c4c-41ce-9609-80f5efa0375c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN18b79449-5c4c-41ce-9609-80f5efa0375c18
308416aspirin 81 MG Delayed Release Oral TabletSCD18b79449-5c4c-41ce-9609-80f5efa0375c18
308416ASA 81 MG Delayed Release Oral TabletSY18b79449-5c4c-41ce-9609-80f5efa0375c18
308416aspirin 81 MG Enteric Coated Oral TabletSY18b79449-5c4c-41ce-9609-80f5efa0375c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-563-06411630563061 BOTTLE, PLASTIC in 1 CARTON (41163-563-06) / 200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
41163-563-17411630563171 BOTTLE, PLASTIC in 1 CARTON (41163-563-17) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
41163-563-32411630563321 BOTTLE, PLASTIC in 1 CARTON (41163-563-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent