FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
49035-563
11-digit product format
490350563
Labeler code
49035
Product ID
49035-563_ea158083-c7a0-4b01-aa1d-d0e41bdc5e70
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores 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

Additional Listing Data#

Finished product
Yes
Brand name base
Low Dose Aspirin
Listing expiration
2027-12-31

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
49035-563-11Low Dose Aspirin60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6020
49035-563-11Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE120
49035-563-13Low Dose Aspirin250 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE25020
49035-563-13Low Dose Aspirin2 in 1 CARTONTABLET, DELAYED RELEASE220
49035-563-14Low Dose Aspirin500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50020
49035-563-17Low Dose Aspirin300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30020
49035-563-27Low Dose Aspirin32 in 1 BOTTLETABLET, DELAYED RELEASE3220
49035-563-27Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE120
49035-563-32Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE120
49035-563-32Low Dose Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12020
49035-563-96Low Dose Aspirin250 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE25020
49035-563-96Low Dose Aspirin2 in 1 CARTONTABLET, DELAYED RELEASE220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-563-11EA - Each49035-563ebec318f-1f12-41f5-a80f-930e60b07c7112023-04-07
49035-563-14EA - Each49035-563cd68088e-ceaf-4855-b61c-e4642386350512016-03-04
49035-563-17EA - Each49035-563f22db8dc-c419-4a04-98ef-288aa123113b12013-02-13
49035-563-32EA - Each49035-563245bd25d-686d-4f7d-80b2-d950025d481312013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
ASPIRINACTIVE MOIETYR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
SHELLACINACTIVE INGREDIENT46N107B71OLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-563LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [WAL-MART STORES INC]19Current NDC, Legacy NDC, 12 package rows20250519_093e0458-9975-456f-8950-8273c8890b3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN093e0458-9975-456f-8950-8273c8890b3c20
308416aspirin 81 MG Delayed Release Oral TabletSCD093e0458-9975-456f-8950-8273c8890b3c20
308416ASA 81 MG Delayed Release Oral TabletSY093e0458-9975-456f-8950-8273c8890b3c20
308416aspirin 81 MG Enteric Coated Oral TabletSY093e0458-9975-456f-8950-8273c8890b3c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-563-11490350563111 BOTTLE, PLASTIC in 1 CARTON (49035-563-11) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
49035-563-13490350563132 BOTTLE, PLASTIC in 1 CARTON (49035-563-13) / 250 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-012027-04-30NoNoCurrent
49035-563-1449035056314500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49035-563-14) 2011-05-010000-00-00NoNoCurrent
49035-563-1749035056317300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49035-563-17) 2011-05-010000-00-00NoNoCurrent
49035-563-27490350563271 BOTTLE in 1 CARTON (49035-563-27) > 32 TABLET in 1 BOTTLE1 bottle2011-05-010000-00-00NoNoCurrent
49035-563-32490350563321 BOTTLE, PLASTIC in 1 CARTON (49035-563-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
49035-563-96490350563962 BOTTLE in 1 CARTON (49035-563-96) > 250 TABLET in 1 BOTTLE2 bottle2011-05-010000-00-00NoNoCurrent